cyrilzakka/clinical-trials huggingface dataset:
Lille Study for Childhood Health Promotion

Obesity could be avoided but once declared it become a chronic disease with numerous health complications, including cardiovascular and metabolic diseases, cancers, and finally a loss of life expectancy. Considering that after the age of 6 years old, half of the obese children will become obese adults, the WHO has been declared childhood obesity prevention as a health priority area. Large-scale prevention of obesity is challenging and it would be more efficient to proceed to early identification of high risks children to implement personalized prevention.

The ELIPSE study main objective is to evaluate the efficacy of personalized multidisciplinary care to reduce the BMI of overweight or obese children. A 2 years educational program will be evaluated at short and longer terms (after a 12 months follow-up), and its benefits will also be assessed based on comparison with a historical control group.

Along with efficacy evaluation, scientific objectives were designed to investigate clinical, genetic, social, and behavioural risk factors and to analyse potential correlations between these factors and a predisposition to overweight or obesity. Moreover, advanced analyses will be performed to decipher the impact of diverse risk profiles on the efficacy of the educational program.

The motive of the ELIPSE study is to promote the health and well-being of children and their families to tackle the health burden represented by childhood overweight and obesity. Combined with innovative scientific objectives, this study ambitions to develop more efficient and more personalized preventive care methods.


Eligibility Criteria:
Inclusion Criteria:

* Children from the first year of primary school in Lille City
* Overweight or obese children as defined by the IOTF and/or with at least one of the following risk factors: 1) early adiposity rebound (before 6 years old), 2) an upward crossing of major percentiles on the BMI curve (after 6 years old).
* Children whose legal tutor(s) is(are) able to understand the enlightened information.
* Children whose legal tutor(s) has(ve) signed the free and informed consent.

Exclusion Criteria:

* Refusal from children or their tutors to participate in the study.
* Impossibility to participate in the study in its totality.
* Pathology known to impact the BMI: follow-up care for eating behaviour problems, endocrine disorders (hypercorticism, hypothyroidism, growth factor deficiency, hypothalamic-hypophysis lesions), genetic disorders (Prader Willi syndrome, Bardet-Biedl syndrome), drugs that affect body weight (antidepressant, neuroleptics, corticoids).
* Previous participation in a similar educational program.
The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium

The purpose of this study is to investigate the efficacy of the granulocyte-macrophage colony stimulating factor(GM-CSF) gel on the endometrial thickness in infertile women with thin endometrium.

The thin endometrium is detrimental to embryo implantation, probability of clinical pregnancy for an endometrial thickness ≤ 7 mm was significantly lower compared with cases with endometrial thickness \> 7 mm. It has been reported the granulocyte colony stimulating factor (G-CSF) increased the endometrial thickness and pregnancy rate of infertile women with thin endometrium during IVF cycle. However, most of the researches were retrospective and small sample size, and the results were conflicted among them. GM-CSF is another member of CSF superfamily, recalling more macrophage than G-CSF, which could be more effective in local homeostasis maintain and wound repair. GM-CSF has been widely used in skin repair after burn. It was also found the GM-CSF and its receptor in endometrium. In the past year, the investigators tried GM-CSF irrigation in 21 women with thin endometrium and most of them received GM-CSF after hysteroscopic examination or slight adhesion relaxing, and the preliminary data suggested that the GM-CSF may promote the endometrial growth. Does the GM-CSF gel can improve the endometrial thickness? Therefore, this study was conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Woman undergoes IVF treatment, 18-40 years old
2. The endometrial thickness \<7mm on the day of human chorionic gonadotropin during IVF or after taking oral estradiol valerate 6mg/d for 14 days.
3. Embryo transfer is cancelled because of thin endometrium
4. No intrauterine adhesion according to the 3-D ultrasonography

Exclusion Criteria:

1. Systemic diseases unable to conceive
2. Chromasome abnormal
3. History of G-CSF or GM-CSF allergy or untoward effect
4. Thin endometrium related to clomid
5. Severe or moderate uterine adhesion
6. The influence factor of embryo implantation: hydrosalpinx, endometriosis, adenomyosis,myoma of uterus
7. Uterine malformation, adenomyosis, uterine leiomyoma sized more than 2cm.
8. Patients who is allergic to granulocyte-macrophage colony stimulating factor
9. Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia
Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?

Patients who on taking clopidogrel are randomized to either continue clopidogrel into general surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel after surgery. The investigators track the development of bleeding complications that may develop within 90 days of the surgery. Patients are medically cleared to be in either arm of the study by their cardiologist and surgeon. There is currently no evidence to support for or against the use continuation or discontinuation of clopidogrel prior to general surgery.

A medical record review was performed of 104 consecutive patients undergoing general surgical procedures while receiving antiplatelet therapy. Patients were identified from an administrative database by crossreferencing clopidogrel with abdominal operative procedures. The records of only patients who were actively receiving antiplatelet therapy, with the last clopidogrel dose within 45 days of their operation, were considered in the study.

Eligibility Criteria:
Inclusion Criteria:

* taking clopidogrel
* undergoing general surgery
* cleared by both cardiologist and surgery for randomized arm

Exclusion Criteria:

* previous history of bleeding complications/bleeding disposition
* no capacity to consent
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.

The objective of this study is to evaluate the safety, tolerability, and antitumor activity of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in participants with metastatic pancreatic cancer.

This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and pharmacokinetics (PK) of oleclumab with or without durvalumab in combination with chemotherapy administered in participants with metastatic pancreatic ductal adenocarcinoma (PDAC). Participants with previously untreated metastatic PDAC (first-line \[1L\] metastatic PDAC) will be enrolled in Cohort A. Participants with metastatic PDAC previously treated with gemcitabine-based chemotherapy (without exposure to 5-fluorouracil \[5-FU\], capecitabine, or oxaliplatin; second-line \[2L\] metastatic PDAC) will be enrolled in Cohort B. The study consists of 2 parts, dose escalation (Part 1) and dose expansion (Part 2).

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18
2. Written and signed informed consent must be obtained
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
4. Weight \>= 35 kg
5. Participants must have histologically or cytologically, confirmed pancreatic adenocarcinoma:

   Cohort A: Participants with previously untreated metastatic pancreatic adenocarcinoma (1L metastatic disease) not previously treated with systemic therapies Cohort B: Participants with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2L metastatic disease
6. Participants must have at least 1 measurable lesion according to RECIST v1.1
7. All Participants must consent to providing archival tumor specimens.

Exclusion Criteria:

1. Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.
2. Prior receipt of any immune-related therapy
3. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed.
4. Participants with a history of venous thrombosis within the past 3 months
5. Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
6. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
7. Other invasive malignancy within 2 years
8. Any history of leptomeningeal disease or cord compression
9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose.
Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic

Patients of arsenical keratosis may be treated with spirulina. Is this improvement related to the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? To understand this, patients of palmer arsenical keratosis (n=10), arsenic exposed controls (n=10) and healthy volunteers (n=10) will be treated with spirulina powder 10 g/day orally for 12 weeks. Skin extracts will be collected both before and after supplementation from the palm and dorsum for estimation of zinc, vitamin E and linoleic acid levels.

Patients of arsenical keratosis remain untreated due to unavailability of effective drug. To find out an effective drug, the pathogenesis of keratosis should be understood. Spirulina is one of the dietary supplements, that improves the symptoms of keratosis. Is this improvement related to the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? Ten patients of moderate palmer arsenical keratosis will be treated with spirulina powder 10 g/day orally for 12 weeks. Skin extracts will be collected both before and after supplementation from the palm and dorsum using a mixture of chloroform and ethanol. Zinc, vitamin E and linoleic acid levels will be estimated from the extracts. Similar protocol of spirulina administration and the collection of skin extracts will be done in arsenic exposed controls (n=10) and healthy volunteers (n=10).

Eligibility Criteria:
Inclusion Criteria (Patients):

* moderate palmer keratosis
* drink arsenic contaminated water (\>50 µg/L) for at least 6 months
* voluntarily agree to participate

Inclusion Criteria (Arsenic exposed controls):

* no symptoms of keratosis
* family member of the patient
* drink arsenic contaminated water (\>50 µg/L) for at least 6 months
* voluntarily agree to participate

Inclusion Criteria (Healthy volunteers):

* no symptoms of keratosis
* drink arsenic safe water (\<50 µg/L)
* voluntarily agree to participate

Exclusion Criteria:

* pregnancy
* lactation
* chronic diseases: diabetes mellitus, rheumatoid arthritis, tuberculosis
* arsenicosis patients under treatment in the previous 3 months
Effect of Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve.

Declined fertility and ovarian reserve in older women are associated with lower density of Growth hormone (GH) receptors and dysregulation in GH secretion. GH can regulate the expression of growth hormone receptor and strengthen the function of mitochondria, which could improve the quality of the female oocyte. In this study, a prospective randomized control will be conducted to explore the effect of GH adjuvant therapy on clinical outcome of in vitro fertilization.

Eligible subjects will be randomly assigned into either the study groups (receive somatropin co-treatment) or the control group (without sopmatropin treatment). Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) for approximately 6 weeks, i.e. from the beginning of preceding menstruation cycle until the day of ovum pickup. Both groups will receive a similar common protocol for ovarian stimulation. In vitro fertilization with or without intracytoplasmic sperm injection will be performed according to semen parameters. All embryos will undergo culture for blastocyst and the obtained blastocysts will be vitrified for deferred frozen embryo transfer. The Blastocyst formation rate will be the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* 1)Married women between 35-40 years old; 2) serum AMH\< 1.2ng/ml, and basal FSH\<20IU/L during the screening period or within 6 months; 3) 18kg/m2≤BMI\<30kg/m2; 4) Previous ART cycles \<3.

Exclusion Criteria:

* 1）Gynecological diseases that affect pregnancy outcomes, such as submucous uterine myoma, intramural uterine myoma≥4cm, Ovarian cyst≥4cm, endometriosis, Uterine malformation, Tuberculosis of reproductive system; 2) Spontaneous abortion≥3 times; 3) Chromosomal abnormalities (except polymorphism) in one or both spouses; 4) Patients with well-defined and uncontrolled endocrine, metabolic, and adrenal diseases, such as diabetes, thyroid disease, Cushing's syndrome; 5) Patients with malignant tumors; 6) Previous use of somatropin products.
Effects of Dual-Task and Progressive Wall Squat Training in Stroke Survivors

To determine the Effects of Dual-Task and Progressive Wall Squat Training on Cognition, Balance and Functional mobility in Stroke Survivors.

A stroke is a neurological disorder in which clots or ruptured vessels obstruct blood vessels, causing abnormal blood flow in the brain. This may lead to the unexpected death of brain cells and aggravate illnesses like depression and dementia.It is a disease with significant health and social consequences because of its high frequency and rate. Stroke is thought to affect 9.2% of the population in Europe, with a rate of 191.9 per 100,000 people annually. According to estimates, between 25 and 74% of those who survive this illness need assistance or become totally reliant on their everyday activities.The primary long-term effects of a stroke are dysphagia, paralysis, motor impairments, cognitive decline, and speech difficulties.

Dual-task training entails doing a motor task and a cognitive task at the same time. This method's justification is that a lot of daily tasks necessitate multitasking, and dual-task training can improve both cognitive and motor abilities by promoting brain plasticity and the interaction of the two systems. In the dual task training, cognitive task (like naming animals or counting backwards) is combined with a lower limb strengthening exercise called wall squats. Both tasks gradually increase in difficulty and intensity based on how well each person performs. By testing the muscle strength, endurance, and coordination of stroke survivors as well as their attention, memory, and executive function, this training seeks to improve their cognitive abilities, balance, and functional mobility.

Eligibility Criteria:
Inclusion Criteria:

* Age: Stroke patients aged 45 to 65 years.
* Individuals with a single ischemic stroke.
* Within the first 2 months post-stroke. (Subacute stage)
* Medically stable without acute conditions interfering with exercise.
* Mini-Mental State Examination (MMSE) score≥24
* Ability to walk 10m without assistance

Exclusion Criteria:

* Unstable Medical Conditions (cardiovascular, respiratory, or other medical conditions)
* Recent Stroke or Medical Event
* Other Neurological Conditions such as Presence of other neurological conditions (e.g., Parkinson's disease).
* Uncontrolled Hypertension: Systolic BP \>160 mm Hg or diastolic BP \>100 mm Hg
The Effect of Obturator Thickness on the Function

the effect of obturator bulb thickness on masticatory function has been verified.


Eligibility Criteria:
Inclusion Criteria:

* having maxillectomy operation

Exclusion Criteria:

* having radiation therapy before the study
Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study

The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are able to speak Danish \> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
* Normal EKG, blood pressure and pulse
* Signed informed written consent

Exclusion Criteria:

* Medical reason that contraindicates physical activity
* Patients diagnosed with a symptomatic cardiac disease within the last three months.
* Documented bone metastasis
* Dementia, psychotic
* Cannot write or read Danish
* Patients unable to carry out baseline tests
A Comparison of Redrubber Versus Penrose Drains

All patients presenting to Grady Memorial Hospital with an odontogenic (dental) infection that requires admission to the hospital and incision and drainage will be eligible for inclusion in this pilot study. The surgical method used for incision and drainage will be determined by the attending surgeon who will operate on the patient. The surgical procedure is a simple and universally standardized involving one or more small incisions in the mouth or in the upper neck and the placement of a drain(s) within the infected area to facilitate continued drainage of pus. Subjects will be randomized to either a red rubber or penrose drain(s). The drains are placed through the mouth or upper neck depending on the location of the infection and typically remain in place until the drainage has stopped (several days). All drains are secured with a single stitch through the gum or skin. The drain(s) will be removed bedside by removing a single suture and gently withdrawing the drain. The timing of this is determined by the clinical picture although this typically occurs within the first week. This is not a painful procedure. Currently some surgeons place red rubber drains which, after placement, allow the infection not only to drain but also be irrigated with saline both during the surgery and in the immediate post-operative period. Other surgeons place penrose drains, which, after placement, continue to allow the infection to drain but cannot be irrigated. Red rubber drains require daily irrigation and as such are labor intensive. Furthermore, drains that are irrigated may continue to drain the saline irrigant in the many hours after irrigation that upon clinical inspection may be difficult to distinguish from sero-sanguinous (pus) drainage. It is daily inspection of the drainage (or lack thereof) which determines the appropriate time to remove the drain(s). This in turn may influence time to discharge and ultimately hospital costs


Eligibility Criteria:
Inclusion Criteria:

* age 16 and older

Exclusion Criteria:

* none
Hand Training Device For Cognitive Care

Previous studies indicated that auditory stimulation as an external cue might have positive impacts on sensorimotor synchronization. Additionally, according to previous reports apart from traditional interventions, digitized game-based device, such as FTOMBVG, are beneficial for the brain activation in elderly. Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with cognitive decline. Therefore, this study aims to develop an advanced systems based on the previous one, that can provide hand function rehabilitation, cognitive training, and emotional comfort for the elderly or people suffer from cognitive deficiency. They can enhance their finger force control or visual to motor synchronization by music embedded during the gaming process.


Eligibility Criteria:
Inclusion Criteria:

* Ability to communicate in Mandarin Chinese or Taiwanese
* MCI, according to clinical neurological assessment, Montreal Cognitive Assessment (MoCA):≦25\&≧19
* Ability to perform ADL independently, no hand function disability
* Voluntarily participation and ability to sign the informed consent form

Exclusion Criteria:

* Alzheimers disease diagnosed by physicians or meeting the diagnostic criteria for dementia
* Physician's diagnosis of stroke
* Any mental illness or behavior problems and inability to cooperate with the trainer
* Visual impairment or hand diseases resulting in an inability to perform finger press
* received other cognitive or physical training in the past year
* any sight, hearing, or communication impairment
Naloxone Methadone Combination (NAMEKO)

The aim of the study is to examine the tolerability and abuse potential of the diluted methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution treatment.

Study hypothesis: Treatment with this diluted combination product is safer than with methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in opioid dependent patients.


Eligibility Criteria:
Inclusion Criteria:

* opioid dependence
* methadone treatment
* no changes in methadone dose during the last 10 days
* good treatment compliance according to doctor
* normal ALAT and AFOS values (increased if double the normal level)

Exclusion Criteria:

* severe renal or hepatic failure
* acute psychosis
* age under 18
* pregnancy
* legal incompetence
* severe somatic disease
* chaotic situation in life
* medication or disease which is contraindication to study treatment
Peri-Incisional Drug Injection in Lumbar Spine Surgery

This is a randomized prospective study that will compare the use of narcotics in a control group of non-injected patients with a treatment arm of patients injected intra-operatively with a ropivacaine, morphine, and epinephrine cocktail. The investigators hypothesize that this treatment will reduce narcotic use in patients during their hospital stay, and possibly decrease the length of their stay in the hospital.The investigators also hope their pain will be decreased as displayed by their multi-daily Clinically Aligned Pain Assessment (CAPA) score.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient 18 years of age and older who is undergoing surgery for a lumbar spine problem. Common diagnoses in this category would include lumbar disc herniations, spinal stenosis, and spondylolisthesis, but this is not an exhaustive list.

Exclusion Criteria:

* Patients with comorbidities excluding use of proposed injection.
* Patients with major head trauma such that they cannot provide consent or describe their post-operative pain.
* Patients with other surgical treatment during study treatment (i.e. more than 1 surgery during the study period or within 30 days prior to surgery).
* Pregnant women (as assessed by pre-operative pregnancy test, which is standard of care).
* Patients with dementia such that they cannot provide consent or describe their post-operative pain.
* Patients with an allergy to study medications.
* Patients with previous drug dependencies.
* Any patient that refuses to be randomized or does not wish to enroll.
* Vulnerable populations, such as prisoners.
* Patients with a fracture, tumor, or infection as their primary diagnosis.
* Patients undergoing a deformity correction.
* Patients with surgeries extending more than 4 levels, with surgeries that extend to the pelvis, or with surgeries that cross the thoracolumbar junction.