cyrilzakka/clinical-trials huggingface dataset:
Executive Function Training in Childhood Obesity: Food Choice, Quality of Life and Brain Connectivity

This study evaluates if executive function training in obese children can improve food-related choices and produce cognitive and neuroimaging changes, but also improve psychological and physical status and quality of life measures.

Based on the limited success of current behavioural weight-loss programmes and coupled with data on executive function deficiencies in obesity, this study aims to explore the impact of executive function training on food-related choices, cognitive and neuroimaging outcomes, but also on the psychological and physical status and quality of life measures.

The specific hypotheses are:

1. Obese children undergoing the training programme will perform better than those receiving the control programme in cognitive, emotional state, physical activity and quality of life measures at the end of the intervention and follow-up at 12 months.
2. Obese children receiving the training programme will take better food-related decisions at the end of the intervention and follow-up at 12 months.
3. Obese children receiving the training programme will show changes in brain connectivity, which will be observable immediately at the end of the intervention and during the follow up period at 12 months.
4. There will be an association between changes in neuroimaging biomarkers and food choice, cognitive, emotional, physical and quality of life outcomes in individuals receiving training.

Eligibility Criteria:
Inclusion Criteria:

* Being obese according to the criteria by Cole et al., (2000)

Exclusion Criteria:

* Neurological, psychiatric or developmental disorder.
Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).


Eligibility Criteria:
Inclusion Criteria:

* 18 years old≤Age≤65 years old, male or female;
* Diagnosis of HS for at least 6 months;
* HS lesions must be present in at least two distinct anatomical areas, one of which must be at least located in the apocrine sweat gland area and Hurley Stage II or Hurley Stage III;
* Total abscess and inflammatory nodule (AN) count of ≥ 3.

Exclusion Criteria:

* Subject was previously treated with adalimumab or another biologic product during the 3 months before the first administration;
* Subject received any oral antibiotic treatment for HS within 2 weeks before the first administration;
* Subject received any oral retinoids treatment for HS within 4 weeks before the first administration;
* Subject received oral opioids analgesics within 1 week before the first administration;
* Systematic treatment with glucocorticoid or intramural injection within 4 weeks before the first administration;
* History of heart disease or malignancy.
Etiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in Japan

The purpose of this prospective, epidemiological, cohort study is to evaluate the lung microbiome in stable-state chronic obstructive pulmonary disease (COPD) in Japanese participants


Eligibility Criteria:
Inclusion Criteria:

* Participants must be able and willing to comply with the requirements of the protocol.
* Participant must be aged greater than or equal to (\>=)40 years to to less than or equal to (\<=)80 years at the time of signing the informed consent form (ICF).
* Participants must have a record of a clinical diagnosis of COPD, ACOS or CB.
* Participants must have moderate to severe airflow limitation based on spirometry: FEV1 percent predicted normal \>=30 to \<=80 percent (%) and post-bronchodilator FEV1/forced vital capacity (FVC) ratio \<0.7.
* Participants must be symptomatic at Screening, defined as having a CAT score \>=10.
* Participants must have a documented history of at least 1 LRTI treated with antibiotics and/or oral/systemic corticosteroids.
* Participants must be current or former tobacco (cigarette) smokers with a smoking history of \>=10 pack-years.
* Participants may be male or female. For female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding. Women of non-childbearing potential can also participate. A woman of childbearing potential must have had a highly sensitive negative urine pregnancy test.
* Participants should be able to provide a spontaneous or induced sputum sample of \>=0.2 grams (g) at the Screening Visit.

Exclusion Criteria:

* Participants with a diagnosed respiratory disorder other than COPD, ACOS or CB.
* Participants with a diagnosis of alpha-1 antitrypsin deficiency as the underlying cause of COPD.
* Participants who have received antibiotics within 1 month of Screening or have received antibiotics for more than 30 days within 90 days prior to Screening; Except for those who have received and are currently receiving long-term treatment with low-dose macrolide: erythromycin \<=600 milligrams (mg) per (/) day or clarithromycin \<=200 mg/day.
* Participants who have received systemic corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to giving informed consent.
* Participants who are unable to use or to comply with daily completion of the eDiary.
A Phase I Study of iPS Cell Generation From Patients With COPD

As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing Thoracic Surgery at the Mayo Clinic Rochester
* Presence of a Thoracic Disease
The Butler-Program 2.0: An Internet Platform for Elderly

In this study, effectiveness of an internet based intervention (Butler 2.0) for elderly is tested. Participants (n= 60) will be randomly assigned to two different groups (intervention vs. waitlist). Outcomes in terms of loneliness and quality of life will be assessed at pre-, post (6 weeks) and follow-up (3 months).

Elderly people (age 65+ ) in Zurich will have access to the Butler program 2.0. Butler 2.0 has been designed for elderly with little experience in the use of computers. Several means of communication such as e-mail, video conferencing, chat and a blog are united on this platform. Furthermore, relaxation exercises are offered in the form of virtual walks.

Eligibility Criteria:
Inclusion Criteria:

* age: 65 years or older
* comprehension of German language
* access to Internet

Exclusion Criteria:

* suicidality
* poor eyesight which makes use of intervention impossible
The Effect of a Comprehensive Rehabilitation Program Using Robotic Walking and Functional Electrical Stimulation Technologies on Balance and Walking in Children With Cerebral Palsy

The aim of this study was to investigate the effect of a comprehensive rehabilitation program using robotic walking and functional electrical stimulation technologies on balance and gait in children with cerebral palsy. This study was planned as a prospective observational study. A total of 30 patients in two groups were planned to be included in the study. Patients in both groups were planned to receive a 6-week conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. The case group was planned to consist of patients who received a comprehensive rehabilitation program using high-tech devices including functional electrical stimulation (FES) and robotic rehabilitation applications in addition to the conventional rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 2-18
* Being diagnosed with cerebral palsy
* Walking independently with or without an assistive walking device
* Having a GMFCS score between 1-3
* Lack of seizure history
* Showing consent to participate in the study (signing the informed consent by the legal guardian of the patient)

Exclusion Criteria:

* Presence of contracture in lower extremities
* Being administered botulinum toxin within the last one month before treatment or during the 6-week treatment period
* Being unable to cooperate with clinical assessments
the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee

The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.

It is an open clinical trial. Among the patients who received autologous cartilage cell graft using CHONDRON (autologous cartilage cells) in the past (investigational group) or microfracture (control group), the subjects who agreed to participate in the trial voluntarily will undergo the screening process that assesses the suitability of the subjects to the clinical trial and participate in the clinical trial. During the clinical trial period, the subjects should follow the instruction of clinician in charge. Hospital visit is total 2 times\* regularly. At the visit, to evaluate the efficacy according to the protocol, the subject will be examined by clinicians, MRI test, and X-ray. If the selection time and the visit time are same, hospital visit will be one time\*.

Eligibility Criteria:
Inclusion Criteria:

- 1. Patients who underwent autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago.

2. Patients who meet the above criteria 1, the patient or a guardian agreed to participate in the clinical trial, and signed a written agreement form

Exclusion Criteria:

- 1. Patients with psychological disease or other patients who are determined to be unsuitable to this clinical trial by the investigators conducting the clinical trial.

2. Patients who underwent autologous chondrocyte implantation applying CHONDRON (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.
Endometriosis and Psychological Support

Endometriosis is a common disease, causing significant pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically reducing patients' quality of life.

Endometriosis surgery is often a stressful event for the patient. For that reason, psychological support can improve patients' general health state.

Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.

Psychological support is offered to all women one month before and one month after surgery. A group of patients will receive intensive psychological support during hospitalization.

Patients are divided into 2 groups:

Group A: patients receiving intensive psychological support during hospitalization

Group B: patients not receiving intensive psychological support during hospitalization

After surgery, patients will be included in the post-operative follow-up, as usual in the investigator's clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery for endometriosis
* Patients that have signed an informed consent

Exclusion Criteria:

* Patients with active or history of psychological/psychiatric diseases
* Patients that refuse psychological support
The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19

40 COVID-19 survivors that have been discharged from the hospital will be included in this investigator-blinded randomised study with a 12-week exercise intervention. Patients will be 1:1 block-randomised by sex to either a supervised high intensity interval-based exercise group or standard care (control group).

40 patients will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, Pulmonary function, VO2max, RM, plasma volume, AX3, CGM, echocardiography, cardiac MRI.

After baseline testing, participants will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, both groups will complete a series of follow-up tests (as baseline testing). A 1-year follow-up experimental day is also planned in order to evaluate fitness, cardiac and pulmonary structure and function.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years
* A laboratory-confirmed initial positive test followed by one negative tests of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 6 months after hospital discharge
* ≤10 L oxygen requirement during hospitalization

Exclusion Criteria:

* Present atrial fibrillation
* Diagnosed with acute myocarditis
* Health conditions that prevent participating in the exercise intervention
* Patients who cannot undergo MR scans (e.g. kidney disease or metallic implants)
* Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.
Totally Implantable Venous Access Devices: Quality of Life and Body Image

Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients modify body image and self-representation. Therefore, the purpose of this study is to evaluate the efficacy of psychological intervention on patients undergone this surgical practice.


Eligibility Criteria:
Inclusion Criteria:

* neoplastic patients
* adults
* not visible demolitive interventions
* not psychopathological diagnosis
* language understanding

Exclusion Criteria:

* not neoplastic patients
* psychopathological diagnosis
* language misunderstanding
Look at Food and Lose Your Fear - Evaluation of a Computerized Attention Training (CAT) for Anorexia Nervosa Patients

The purpose of this study is to test the therapeutic effects of a computerized attention training for patients with Anorexia Nervosa (AN). The primary aim is to determine if a computerized attention training can modify attention towards food and ameliorate eating disorder symptoms and related difficulties, such as anxiety. The secondary aim is to explore underlying mechanisms that contribute to these improvements. The stability of potentially observed effects over a one-month period will also be determined.

Recently, attention bias modification (ABM) has successfully been applied in the field of anxiety disorders and emerging evidence suggests that attention bias modification can ameliorate attention bias for threatening stimuli. ABM is based on the premise that if biased attention maintains disorder symptoms, a modification of the bias should reduce symptoms. The advantage of ABM is that it operates implicitly, thereby offering a more indirect, less deliberate procedure. This requires less cognitive control compared to the effortful and explicit psychotherapeutic treatment of cognitive biases. As food-related fears and avoidance in AN patients have been recognized as important anxiety-related symptoms, ABM seems particularly suitable to treat food-related fears and avoidance, especially because AN patients might be unaware of their avoidance strategy. The aim of this study is to test if food-related fears and food avoidance can be changed by experimentally modifying attention towards food in Anorexia Nervosa patients using an innovative computerized training paradigm (computerized attention training - CAT) and to evaluate related change in symptoms.

The investigators hypothesize that the active CAT will change attentional processing of food cues (research aim 1), transfer to changes in food-related fears and food avoidance, and to improvements in AN symptoms and weight in the short term (research aim 2) and longer term (research aim 3).

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 18.5 5 kg/m2
* Current diagnosis of AN-restricting type, AN-Binge/purging type or Eating Disorder Not Otherwise Specified (EDNOS) - Anorexia type
* Fluent in English

Exclusion Criteria:

* Currently taking a dose of any psychoactive medication that has not been stable for at least 14 days prior to participation in the study
* Currently meeting the diagnostic criteria of another major psychiatric disorder (e.g., major depressive disorder, substance dependence, schizophrenia or bipolar disorder) needing treatment in its own right
* Learning and developmental impairments
* If the disorder is currently life threatening
* If patients are currently suicidal
* If patients are currently having extreme physiological complications or co-morbid alcohol and drug-abuse disorders
A Study on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Pregnant Women

The purpose of this study was to understand women with low arched feet, flat feet, or BMI\> 29 in the third trimester.

The purpose of this study was to understand women with low arched feet, flat feet, or BMI\> 29 in the third trimester. Compare the intervention measures of different foot pads immediately, two weeks, four weeks, and six weeks after the intervention Immediate and long-term benefits in relief of plantar pressure, dynamic and static balance, and lower back pain.

Eligibility Criteria:
Inclusion Criteria:

* able to understand and write Chinese
* health and third trimester women
* low arched feet or flat feet or BMI\> 29

Exclusion Criteria:

* Women with a medical record of back, foot, ankle, knee, musculoskeletal, or neuromuscular trauma or disease
Anti-Mullerian Hormone (AMH) as Marker of Ovarian Reserve

This is a multicentre, prospective study willing to evaluate AMH levels changes in response to chemotherapy plus GnRHa.

In the present study we propose to determine AMH levels in breast cancer patients, aged \<40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa.

Patients will receive 4 to 8 cycles of chemotherapy according to Institutional guidelines. Triptorelin 3.75 will be administered as an intramuscular injection before chemotherapy and every 28 days thereafter for all the duration of chemotherapy in patients with ER negative tumors and for 2 to 5 years in patients with ER positive tumors according to Institutional guidelines. Patients with ER+ve tumour will receive tamoxifen for 5 years at the end of chemotherapy as standard care. A blood sample will be drawn after signed informed consent to determine baseline AMH levels. A blood sample for determination of AMH levels will be collected at the end of chemotherapy and at 12 months after the end of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Female subjects, aged \<40yr at the time of breast cancer diagnosis
2. Diagnosis of operable breast cancer any T and N, any ER
3. Patients candidate to adjuvant chemotherapy for 4-8 cycles.
4. Patients compliant to adhere to all protocol procedures.
5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 28 days prior to the start of the study treatment.
6. Negative pregnancy test at the study enrolment; fertile women must use effective contraception during chemotherapy
7. Patients must be able to understand and sign written informed consent.

   -

Exclusion Criteria:

1. Presence of distant metastasis
2. Clinically significant cardiovascular disease
3. Psychological or social conditions which might affect study compliance
4. Unstable neurologic function
5. Patients with known allergy to any of the components of the study medication
6. Pregnancy or lactation
7. Any condition that, in the opinion of the physician is likely to affect inclusion of the subject into the study.
Cyclophosphamide in the Treatment of Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes

This study evaluates the change of insulin resistance and glucose metabolism of patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes with the treatment of cyclophosphamide.

Patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes have difficulty in blood glucose management due to the presence of both severe insulin resistance and complete insulin deficiency. It is often necessary to use insulin doses several times that of other children of the same age with type 1 diabetes.

Since autoimmune response is the main cause of panniculitis associated acquired lipodystrophy syndrome, immunosuppressive agents can suppress immune response, prevent and alleviate the progression of panniculitis and acquired lipodystrophy syndrome, and improve insulin resistance caused by subcutaneous fat deficiency.

Cyclophosphamide is a classic immunosuppressive agent. This study hopes to improve insulin resistance of patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes by cyclophosphamide treatment, thereby reducing insulin dosage and improving glucose metabolism.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of type 1 diabetes mellitus: clinical manifestations of typical diabetes mellitus include polyphagia, polyuria, weight loss, or diabetic ketoacidosis, confirmed by blood sugar level, islet function and autoimmune antibody.
2. Meet the diagnostic criteria for panniculitis: fat biopsy suggests inflammatory infiltration.
3. Meet the diagnostic criteria for acquired lipodystrophy syndrome: childhood onset, clinically no nutritional deficiency or catabolism, systemic or partial subcutaneous fat reduction, genetic testing to exclude congenital lipodystrophy syndrome; low leptin level and autoantibodies can aid in diagnosis.

Exclusion Criteria:

1. Mature and effective treatment methods are available.
2. HIV, HBV and HCV were positive.
3. A the active period of infection.
4. At the active stage of malignant tumors.
5. Combination of other fatal diseases.
6. Existence of mental and psychological diseases.