cyrilzakka/clinical-trials huggingface dataset:
Hydration in Children and Adolescents With Primary Headaches

The aim of this study is to investigate the role of hydration and fluid intake in children and adolescents with primary headaches.

Headches are one of the key factors affecting or even limiting the health and well-being of children and adolescents. Lifestyle recommendations could help reduce the risk of chronic headaches and improve overall well-being in this population. In clinical practice, adequate fluid intake is one of the general recommendations for headache management. However, scientific literature on the role of hydration and fluid intake in headaches is limited. To date, all studies have been conducted on adults, and no studies have examined this topic in the pediatric population.

As the first interventional study investigating the impact of adequate fluid intake on headaches in children and adolescents, our study will make a significant contribution to understanding the role of hydration in headache management and developing recommendations for improving headache control in the pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* Age 4-18 years.
* Able to provide informed consent and willing to complete follow-up visits.
* Primary headaches.
* At least 1 headache per month.
* Presence of headaches for at least 3 months or longer.

Exclusion Criteria:

* Secondary headaches.
* Without headaches for 3 months or more.
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears

The aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program.

In our study a common exercise program, which can be used in conservative treatment of a partial rotator cuff tear, is applied with two different methods; a video-based rehabilitation program and physiotherapist-supervised rehabilitation program. Video-based rehabilitation program was developed to investigate whether this program is effective on pain, functionality and quality of life and as successful as a physiotherapist-supervised rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.

Exclusion Criteria:

* Patients that had been diagnosed for a full-thickness or massive rotator cuff tear, operated previously, had frozen shoulder or glenohumeral instability
* Younger than 40-year-old, and athletic patients with acute tear symptom were excluded from this study.
Acute Effect of Sound Healing on Pain, Fatigue and Mood

There is evidence that sound healing improves health and well-being. However, sound healing modalities, such as tuning forks, continue to be understudied, especially among people with chronic illnesses. This study examined responses to a single session of sound healing and explored whether responses varied based on analogue pain, fatigue, and mood.


Eligibility Criteria:
Inclusion Criteria:

* People with long term illnesses who attended 'Tuning for Health' virtual session

Exclusion Criteria:

* Who did not complete 30-mins Sound Healing
Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner

* Selection of patient and preparation of questionnaires
* Presentation of the study by the doctor
* Verbal consent of participants (patient and Partner)
* Delivery of booklets
* Response to documents (questionnaires and written consent) at home, send by mail

1. Before consultation :

   Selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file
2. During the consultation :

   * Presentation of the study by the investigator
   * The investigator signs the information note and give two file to the patient (1 for her and 1 for her Partner : both contains 1 information note signed by the investigator, 1 questionnaire and 2 stamped envelopes
   * Finally, the investigator fill-in the medical form and send the original to the university (université de Lille 3)
3. At home :

   * Signature of the information note and the participation consent form
   * Patients and Partner responds to their questionnaire (including socio-demographique questionnaire)
   * They send the documents thanks to stamped envelopes:

     1. They send information note to the medical center
     2. They send the questionnaires to the university

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old (patient and partner)
* \<45 years old (patient)
* Patient with a non metastatic breast cancer
* Patient treated or previously treated by chemotherapy
* Patient and her Partner live together for at least 6 months when they complete the questionnaires.

Exclusion Criteria:

* Patient or patner with psychiatric trouble
* Native language other than french
Older Adult Training Study With Creatine and CLA

We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM); decrease body fat) following resistance exercise training in older adults (\> 65 y). Our study hypothesized that administering CrM and CLA would yield greater strength and body composition benefits than the placebo group over the six months of resistance exercise

Men (N=19) and women (N=20) completed six months of resistance exercise training with Creatine Monohydrate (5g/d) + Conjugated Linoleic Acid (6g/d) or placebo with randomized, double-blind, allocation.Outcomes included; strength and muscular endurance, functional tasks, body composition (DEXA scan), blood tests (lipids, liver function, CK, glucose, systemic inflammation markers (IL-6, C-reactive protein)), urinary markers of compliance (creatine/creatinine), oxidative stress (8-OH-2dG, 8-isoP) and bone resorption (Ν-telopeptides).

Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* Ambulatory,
* Recreationally active,
* Community dwelling

Exclusion Criteria:

* Evidence of coronary heart disease;
* Congestive heart disease;
* Uncontrolled hypertension;
* Chronic obstructive pulmonary disease;
* Diabetes mellitus;
* Renal failure;
* Major orthopedic disability; and
* Smoking
Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced neuroendocrine tumors.

OBJECTIVES:

* Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors.
* Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 10-31 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven metastatic or unresectable high grade neuroendocrine tumor including:

  * Small cell carcinoma
  * Large cell neuroendocrine carcinoma
  * Other high grade neuroendocrine carcinomas without specification to cell size
  * No lung only involvement without any other primary site
* No primary small cell lung cancer with or without metastases
* Bidimensionally measurable disease with at least one lesion measuring at least 1 cm by 1 cm
* High grade tumor indicated by at least one of the following:

  * Growth pattern suggestive of neuroendocrine differentiation
  * Mitotic rate greater than 15 mitoses per 10 hpf
  * Presence of abundant necrosis
* Immunohistochemical evidence of neuroendocrine differentiation by positive staining for chromogranin, synaptophysin, or neuron specific enolase if no classic microscopic appearance of small cell carcinoma
* No low grade neuroendocrine tumors (e.g., carcinoid tumors, pancreatic endocrine tumors) and atypical tumors

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,500/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 75,000/mm\^3

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* SGOT no greater than 5 times ULN

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No myocardial infarction within the past 6 months
* No uncontrolled congestive heart failure requiring therapy

Other:

* No active or uncontrolled infection
* HIV negative
* No psychiatric or other disorder that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No more than 2 prior chemotherapy regimens
* No prior camptothecins

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder

The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, and repetitive behaviors. We expect to provide evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on secondary outcomes of social impairment, language delay, and repetitive behavior, as well as on functional outcomes of global severity.

IGF-1 is an FDA approved, commercially available compound that crosses the blood-brain barrier and has beneficial effects on synaptic development by promoting neuronal cell survival, synaptic maturation, and synaptic plasticity. IGF-1 is effective in reversing mouse and neuronal models of Rett syndrome and Phelan McDermid syndrome, both single gene causes of ASD and may therefore be effective in treating autism spectrum disorders (ASD) more broadly.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-5 criteria for Autism Spectrum Disorder confirmed by the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule- Generic (ADOS-G)
* Children between the ages of 5-12 years of age
* Language delay (lack of fluent phrase speech) reflected by use of ADOS Module 1 or 2
* Must be on stable medication regimens for at least three months prior to enrollment, assuming the concomitant medication is safe for use with IGF-1

Exclusion Criteria:

* Closed epiphyses
* Active or suspected neoplasia
* Intracranial hypertension
* Hepatic insufficiency
* Renal insufficiency
* Cardiomegaly/valvulopathy
* History of allergy to IGF-1
* Patients with comorbid conditions deemed too medically compromised to tolerate the risk of experimental treatment with IGF-1
The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.

The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.

Eligibility Criteria:
Inclusion Criteria:

* patients with total or partial tonsillectomy with or without adenoidectomy

Exclusion Criteria:

* patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma
* patients who have diabetes
* patients who have bleeding problems
* patients who are suspected to have signs of acute pharyngeal infection
Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).

3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CF older than 18 years
* FEV1 between 20% and 69% of predictive.
* No acute exacerbation.
* No Burkhordelia Cepacia/MRSA colonization.

Exclusion Criteria:

* Children under 18 year
* acute exacerbation.
Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059)

The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for metastatic or locally advanced breast cancer, not amenable to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the following criteria will be eligible for enrollment.

  * Female patients with histologic or cytologic diagnosis of breast cancer that is locally advanced or metastatic, and not amenable to surgery.
  * Age \>= 65 years.
  * World Health Organization (WHO) Performance Status 0 - 2
  * Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Patients with bone metastasis can also be included but will be evaluated according to WHO criteria. Patients with non-measurable disease can also be included.
  * Left ventricular ejection fraction (LVEF) \>= 50% verified by ultrasound cardiography (UCG); no clinical signs of heart disease.
  * Normal organ function, except due to disease involvement, however maximum deviation:

    * S-creatinine \<= 1.5 x upper normal limit;
    * Bilirubin \<= 2 x upper normal limit;
    * Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \<= 3 x upper normal limit. In case of liver metastases, ALAT and/or ASAT \<= 5 x upper normal limit.
  * Adequate bone marrow function, ie:

    * Platelets \>= 100 x 10\^9/L;
    * Neutrophils \>= 1.5 x 10\^9/L;
    * White Blood Cell (WBC) \>= 3.0 x 10\^9/L;
    * Hemoglobin \> 90 g/L.
  * Life expectancy \>= 12 weeks.
  * Patients having received oral and written information and having provided written informed consent.

Exclusion Criteria:

* Patients will not be enrolled if any of the following conditions apply.

  * Previous chemotherapy for metastatic disease. (The patient may have received previous endocrine therapy or single-drug Herceptin. Intrapleural or intrapericardial Novantrone is allowed.)
  * Recurrence \<= 12 months after adjuvant anthracycline-containing treatment and/or prior doxorubicin \> 300 mg/m\^2 or epirubicin \> 540 mg/m\^2.
  * Myocardial infarction within 6 months of planned inclusion.
  * Symptomatic brain metastases.
  * Human Epidermal growth factor Receptor 2 (HER-2) positivity eligible for treatment with trastuzumab, or estrogen receptor (ER) positivity eligible for hormonal therapy.
  * Allergy to anthracyclines.
  * Uncontrolled infection.
  * Other not radically treated malignancy.
  * Other disease or condition contraindicating treatment or not allowing follow-up.
Effects of an Adolescent Physical Activity Promotion Model on Physical Activity in Obese Chinese Children.

The purpose of this study was to evaluate the effectiveness of an intervention program based on the Youth Physical Activity Promotion Model (YPAP) in increasing physical activity levels among overweight and obese children in China.

This observational study aims to understand the impact of a YPAP-based intervention on the psychosocial factors and physical activity of overweight and obese children aged 12-15 in China. The intervention consists of three key components: 1) The intervention group received an 8-week intervention program aimed at gradually increasing their physical activity levels. The intervention program included the following components: 1) 1-2 sessions of moderate-intensity physical activity per week, each lasting 45 minutes, with activities provided by physical activity experts; 2) one health education lecture every two weeks, each lasting 60 minutes; and 3) one family physical activity session per week, each lasting 30 minutes at a lower intensity. At the end of the intervention period, relevant questionnaires were used for measurement.

Eligibility Criteria:
Inclusion Criteria:

* Chinese children
* Aged between 12 and 15 years
* Able to complete questionnaires before and after the intervention
* Children who meet the standards for overweight and obesity among Chinese school-age children

Exclusion Criteria:

* Children with serious health issues (e.g., heart disease, respiratory diseases, severe musculoskeletal disorders) or those advised by a doctor not to participate in physical activities.
* Children currently involved in other intervention programs that affect physical activity or weight.
* Children without written consent from their parents or guardians.
* Children on long-term medication that might affect physical activity or weight (as determined by parents and teachers).
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells.

The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.

The study is looking at:

* The side effects cemiplimab might cause
* How well cemiplimab works


Eligibility Criteria:
Key Inclusion Criteria:

1. Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol
2. Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol
3. Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
5. Adequate hepatic, renal and bone marrow functions, as described in the protocol

Key Exclusion Criteria:

1. Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, basal cell carcinoma, basosquamous.carcinoma, Bowen's disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)
2. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for Immune-mediated Adverse Events (imAEs), as described in the protocol
3. History of non-infectious pneumonitis within the last 5 years
4. TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa

NOTE: Other protocol defined inclusion / exclusion criteria apply.
Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

The aim of this study is to assess the effect of the drug rotigotine on the syndrome of hemispatial neglect and motor deficits following strokes affecting the right hemisphere of the brain.

Hemispatial neglect and motor deficits remain major problems following right-hemisphere stroke. This study aims to assess the effect of rotigotine on hemispatial neglect, its component cognitive deficits (including spatial working memory and sustained attention) and motor deficits following right-hemisphere stroke.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of right-hemisphere stroke.
* Able to give informed consent.
* Presence of left hemispatial neglect defined by a deficit in finding leftward targets on standard cancellation or visual search tests68-70. (A deficit on the line bisection test alone will not be sufficient for inclusion, as a previous study shows that there is no significant relationship between performance on this test and spatial working memory capacity37).
* Presence of motor deficits: all patients will have suffered from first-ever clinically defined stroke resulting in weakness of at least wrist and finger extensors, and hand interossei (to \</= 4+ on the Medical Research Council scale), at the time of recruitment.
* Age over 18 years.
* More than 9 days since stroke-onset (Note that on our protocol patches do not commence until a minimum of 6 days after the study begins. Thus patients will not receive drug / placebo until a minimum of 15 days post-stroke).
* Able and willing to use patches of drug/placebo and assessments at regular intervals as defined by the protocol.
* Able to comply with study requirements.
* If female and of child-bearing potential, subject has a negative serum pregnancy test within two days of enrollment.

Exclusion Criteria:

* Pre-existing neurological conditions that would confound cognitive and motor assessments, e.g. dementia, Parkinson's disease, Multiple Sclerosis.
* Presence of acute concomitant illness, e.g. infection, unstable angina, myocardial infarction or heart, respiratory, renal or liver failure which, based on clinical judgment, would be considered to confound interpretation of results.
* Systolic blood pressure less than 120 mmHg and / or diastolic less than 70 mmHg.
* Exposure to any other investigational drug within 30 days of enrollment in the study.
* History (obtained from patient and medical records) of clinically significant drug or alcohol abuse within 6 months prior to enrollment into the study.
* Pregnancy (because the effects of rotigotine on the fetus and mother in pregnancy are not known). If female and of child-bearing potential, a serum pregnancy test will be performed within two days of enrollment.
* Mothers who are breast feeding (because the effects of rotigotine on the newborn have not been established)