cyrilzakka/clinical-trials huggingface dataset:
Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety

The purpose of this study is to evaluate the satiating effects of different functional yogurts enriched with soluble fiber or vegetable protein on overweight subjects (BMI ≥25 and \<30 kg / m2).

Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. On the other hand, protein consumption could have a greater satiety potential compared to other macronutrients.

A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of different functional enriched yogurts with soluble fiber or vegetable protein in a group of healthy overweight subjects.

The investigators included 12 participants (6 men and 6 women) between 18 and 55 years (BMI ≥25 and \<30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.

Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 65 years old.
* Body Mass Index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent

Exclusion Criteria:

* Subjects with BMI ≥30 or \<25 kg /m2
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment
* Subjects with hypertension on pharmacological treatment
* Subjects with established diagnosis of eating disorder
* Smokers or those subjects with high alcohol consumption (\> 2-3 servings/ day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer)
* Subjects under pharmacological treatment (except oral contraceptives)
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
* Subjects with sensory problems
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
* Pregnant or breastfeeding women
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months)
* Subjects with intense physical activity.
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
* Subjects with a diagnosis of celiac disease or a gluten intolerance
Quality of Life and Sexual Function of the Novasure Endometrial Ablation in Menorrhagia

The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia.

patients diagnosed menorrhagia scheduled for Novasure Endometrial Ablation because of menorrhagia between november, 2012 and november, 2014 are enrolled to this study.

patients are asked to complete preoperative questionnaires considering Health Related Quality of Life questionnaire(HRQoL) and sexual Female Sexual Functioning Index questionnaire(FSFI). Same questionnaires will also be completed six months and one year after operation.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of menorrhagia
* family complete
* normal endometrial pathology
* had not been referred specifically for surgery
* with normal uterine cavity

Exclusion Criteria:

* pregnancy or demand to preserve fertility
* acute reproductive tract inflammation or urinary tract inflammation
* pathology demonstrate endometrial cancer or precancerous change
* acute pelvic inflammation
* intrauterine device(IUD) in uterus
* depth of uterine cavity less than 4cm or more than 10cm
* pathologic myometrium( such as history of Hysteromyomectomy or classical cesarean section)
Seniors'Health Paths " PAERPA ",

•Background: PAERPA experimentation implemented in the East-Herault region since September 2017 aims to identify fragility and prevent the risk of loss of autonomy in elderly persons older than 60 years by facilitating coordination between Professionals taking care of the patient with the personalized health plan " PPS". The main objective of this study was to evaluate the implementation of this device through the achievement or not of the objectives set by the PPS.

•Methods: Descriptive cohort study with retrospective inclusion and prospective follow-up from the East Herault CTA database. All patients over 60 years old living at home and having a PPS written between September 2017 and April 2018 were included. PPS monitoring for 1 year. Description of this population then analysis of PPS.

•Discussion: Our study aims to evaluate the implementation of the device to identify ways to improve the device for the management of subjects at risk of loss of autonomy.


Eligibility Criteria:
Inclusion Criteria:

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

* Aged of 60 years and more
* individual health care plan was prepared
* living in the Est-Héraultais territory

Exclusion Criteria:

* Hospitalized patients
* Patients who declined to have an individual heath care planPsychosis
Routine Pregnancy Screening for Women on Opioid Substitution Therapy

Women who take opioid substitution therapy have higher rates of unintended pregnancy, more pregnancies, and a higher risk of pregnancy complications than the general population. Current practice is to test for pregnancy only at patient request or if the clinician suspects pregnancy. This study will compare monthly pregnancy testing to current practice in a double blind randomized control trial. As many women of childbearing age as possible will be recruited from the Hamilton Clinic for Opioid Substitutional Therapy. Women assigned to the intervention will have monthly testing at the same time as their monthly urine drug testing at the clinic. The primary objective is to assess if there is a significant difference is early pregnancy detection and the secondary objectives are to assess differences in pregnancy disposition and gestational age at entry to prenatal or abortion care.

The Routine Pregnancy Screening in Women on Opioid Substitutional Therapy study involves screening women from the The Hamilton Clinic for OST regularly for pregnancy to determine if this results in earlier prenatal care and improved pregnancy disposition. All eligible women at the Hamilton clinic will be approached for recruitment. The study phase last for 18 months.

The investigators will assess for any significant difference in the rates of early pregnancy diagnosis, pregnancy disposition, and associated outcome measurements. Study results could inform best practices in the care of child-bearing women on OST and will provide baseline information and feasibility data to inform design of a larger RCT to assess the effect on pregnancy and birth outcomes.

This pilot study will serve to demonstrate whether routine pregnancy screening is effective for earlier pregnancy diagnosis and whether it has any impact on pregnancy disposition and entry into pregnancy-related care for women on OST. In addition, the investigators will also be seeking to address whether routine pregnancy testing is logistically and financially feasible for patients receiving OST at a primary care-run addiction setting. If this intervention is found to be both effective and feasible, it would be possible to apply this study methodology to larger-scale RCTs across multiple clinical sites with the power to assess maternal and fetal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* currently on methadone or buprenorphine maintenance therapy
* have some male sexual partners

Exclusion Criteria:

* females who have exclusively female sexual partners
* a previous diagnosis of premature menopause
* hysterectomy, oophorectomy, and/or tubal ligation
* current pregnancy
* current intrauterine device (hormonal or non-hormonal)
* unable to give informed consent in English
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic
* Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:

  * Calculated creatinine clearance ≤60 mL/min: OR
  * New York Heart Association Classification Stage III-IV Congestive Heart Failure
* Measurable disease documented by imaging with at least one uni-dimensional lesion
* Adequate performance status (ECOG 0, 1, or 2)
* Men and women ≥18 years of age

Exclusion Criteria:

* Patients in whom radiation or surgery is indicated
* Current neuropathy ≥ CTCAE grade 3
* Prior radiation to ≥ 30% of bone marrow
* Inadequate renal function: serum creatinine clearance ≤ 20 mL/min
* Prior allergy to any vinca alkaloid
A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)

According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of full-term small for gestational age, SGA.
* Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
* Prepubertal stage (Tanner I).
* Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
* A GH peak concentration \>10µg/L in a provocative test within a year before participating in the study.
* Bone age\<Chronological age+1.
* Normal glucose regulation：Fasting blood-glucose \< 5.6mmol/L, and 2 hours postprandial blood-glucose \< 7.8mmol/L.
* Gestational age was 37 to 42 weeks.
* The subjects and their guardians signed informed consent.

Exclusion Criteria:

* Subjects with Liver and renal insufficiency (ALT \> 1.5 times of upper limit of normal value, Cr\> upper limit of normal value).
* Patients are positive for antibodies to hepatitis B core (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).
* Known Highly allergic constitution or allergic to the test drug.
* Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
* Subjects with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome and growth hormone receptor deficiency.
* Subjects who have received the treatment of GH.
* Subjects took part in other clinical trial study within 3 months.
* Children who have treated with other hormone (such as gonadal hormone and glucocorticoids etc, continuous administration of more than a month) and that may affect growth hormone secretion or action including oxygen male dragon, growth hormone releasing hormone, etc. within 3 months.
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
Digestive Dysmotility in Mitochondrial Neurogastrointestinal Encephalomyopathy

Mitochondrial neurogastrointestinal encephalopathy (MNGIE) is an ultra-rare mitochondrial disease caused by mutations of the gen that codifies the enzyme thymidine phosphorylase The genetic defect results in systemic accumulation of the nucleosides thymidine and deoxyuridine. Clinically MNGIE is characterized by a combination of gastrointestinal and neurological manifestations, including severe gastrointestinal dysmotility, cachexia, ptosis, external ophthalmoplegia and sensorimotor neuropathy. Gastrointestinal symptoms are the most frequent first manifestation of the disease, and include early satiety, nausea, dysphagia, postprandial emesis, abdominal pain, abdominal distention, and diarrhea. The disease is relentlessly progressive and the cause of death is primarily related to digestive dysmotility. However, the specific motor dysfunctions that produce the symptoms, i.e., the underlying mechanisms, remain uncertain.

Mitochondrial neurogastrointestinal encephalopathy (MNGIE) is an ultra-rare mitochondrial disease caused by mutations of the gen that codifies the enzyme thymidine phosphorylase The genetic defect results in systemic accumulation of the nucleosides thymidine and deoxyuridine. Clinically MNGIE is characterized by a combination of gastrointestinal and neurological manifestations, including severe gastrointestinal dysmotility, cachexia, ptosis, external ophthalmoplegia and sensorimotor neuropathy. Gastrointestinal symptoms are the most frequent first manifestation of the disease, and include early satiety, nausea, dysphagia, postprandial emesis, abdominal pain, abdominal distention, and diarrhea. The disease is relentlessly progressive and the cause of death is primarily related to digestive dysmotility. However, the specific motor dysfunctions that produce the symptoms, i.e., the underlying mechanisms, remain uncertain, because so far, no studies on gastrointestinal motility in MNGIE have been published. The aims of this study were to identify the upper GI motor dysfunction in MNGIE patients, and to determine their relation to the clinical manifestations. Since the life-threatening consequences of the disease involve the upper gastrointestinal tract, all patients, after a thorough clinical and neurological evaluation, fulfilled a structured clinical questionnaire on digestive manifestations, and underwent state-of-the-art evaluation of the esophagus and the small bowel by high-resolution manometry (HRM), and gastric emptying by scintigraphy

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MNGIE disease established by thymidine phosphorylase activity and mitochondrial mutation analysis.
Effectiveness Study of the UltraShape® Contour I-Y for Non-Invasive Reduction in Abdominal Circumference

The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in body circumference.

The primary objective of this study is to evaluate the efficacy of the Contour I - Y System on abdominal circumference reduction relative to baseline pretreatment values using different treatment methods.

The primary efficacy endpoint in this trial is Statistical Difference of Circumference reduction between Baseline measurement and at follow-up measurement.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male subjects, 18-65 years of age at the time of enrollment
2. Abdominal and flank fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)
3. For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment (measured in urine)
4. General good health confirmed by medical history and skin examination of the treated area
5. Written informed consent to participate in the study
6. Ability to comply with the requirements of the study
7. BMI ≤ 30

Exclusion Criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
3. Previous liposuction in the treatment areas
4. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
5. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
6. Poor skin quality (i.e., laxity)
7. Abdominal wall diastasis or hernia on physical examination
8. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
9. Obesity (BMI \> 30)
10. Childbirth within the last 12 months or women who suckling a child
11. Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study
12. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
13. Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
14. Participation in another clinical study
15. Previous body contouring treatments in the abdomen or love handle areas
The Effect of Art Therapy on Physical and Psychological Symptoms of Breast Cancer Survivors

Art Therapy is a health profession in which art making is utilized as a means of expression and communication within a therapeutic and supportive relationship \[1\]. Art therapy has been shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms which accompany many breast cancer patients and survivors \[2-7\]. Qualitative studies provide an initial understanding of the mechanisms through which art therapy facilitates symptom reduction \[8\]. Breast cancer patients have reported that art therapy provided them with access to emotional material otherwise inaccessible \[9\]. The goal of this study is to examine the effect of art making within a therapeutic framework on emotional awareness and acceptance.


Eligibility Criteria:
Inclusion Criteria:

Adult women (over age 18), breast cancer survivors without evidence of active illness, hebrew speaking and receiving preventative hormonal therapy for at least 6 months (steady state), receiving care at the survivor's clinic of Davidoff Medical Center

Exclusion Criteria:

A psychiatric diagnosis requiring medication, functional difficulties that affect the ability to handle art supplies, non-hebrew speaking, unwilling to answer the research questionnaires
The Okla Achokma Project

Deep South Native Americans disparately suffer from diabetes, hypertension, and obesity with only 5-10% of Native Americans living past age 65 compared to 15-17% of Whites. Standard lifestyle interventions to improve diet and physical activity behaviors have shown improvement in weight and other cardiometabolic outcomes among Native Americans. The impact of lifestyle interventions on preventable chronic diseases among Native Americans is limited by the exclusion of a multi-level approach with cultural and social enhancements that address the spiritual and social domains of physical health. Therefore, there is an urgent need to determine how spiritual and social domains of health at individual and family levels may advance lifestyle management interventions.

The overall objective for this study is to determine the effectiveness of a more holistic intervention targeting the individual and family levels to enhance health outcomes and program engagement among Native Americans in the Deep South compared to standard approaches. Our central hypothesis is that the integration of spiritual and social domains of health into the standard lifestyle intervention approach will significantly improve attendance, retention, and cardiometabolic profiles of Deep South Native Americans. This hypothesis is supported by our own preliminary data that health behaviors of Deep South Native Americans are fostered by family support and hindered by fatalistic attitudes. The rationale that underlies the proposed research is that demonstration of the feasibility and effectiveness of an intervention that integrates spiritual and social domains will provide new opportunities for its continued development as a strategy to improve disease management/prevention best practices in Deep South Native Americans.

The specific aims for the study are to develop a conceptual model to define spiritual factors and spiritually- and socially-enhanced intervention components that could advance lifestyle management interventions among Native Americans in the Deep South and to determine feasibility of lifestyle intervention components and study instruments among Native Americans in the Deep South. The plan is to to pilot recruitment methods, standard lifestyle intervention components, and implementation protocol and procedures to assess acceptability, optimize population engagement, and improve fidelity of delivery.

Eligibility Criteria:
Inclusion Criteria:

* men or women who self-identify as Native American
* current resident of the Mississippi study site
* at least 18 years of age or older at the time of enrollment
* BMI ≥ 24kg/m2.

Exclusion Criteria:

* individuals with complicated or contraindicated disease diagnosis (i.e., kidney failure or insulin dependent type 2 diabetes) or who are pregnant or within six weeks postpartum
The Effect of Education Provided to Family Members Caring for Colorectal Cancer Patients on Caregiving Reactions and Healthy Lifestyle Behaviors: A Prospective Quasi-experimental Study.

The effect of education provided to family members caring for colorectal cancer patients on caregiving reactions and healthy lifestyle behaviors: A prospective quasi-experimental study

The study was conducted as a pre-test-post-test, control group and quasi-experimental intervention research design in order to evaluate the effects of education applied to family members who provide care for patients with colorectal cancer on their healthy lifestyle behaviors and reactions towards caregiving. The study population consisted of 100 caregiver who provide primary care to patients with colorectal cancer. The study data were collected using the "Socio-Demographic Characteristics Data Collection Form", "Healthy Lifestyle Behaviors Scale II (HPLP-II)" and the "Caregiver Reaction Assessment (CRA)". The pre-test was applied to the experimental and control groups at the first interview. The preferred interview format was a booklet. Three times face to-face individual educational sessions were provided to the experimental group, accompanied by a education booklet. After the third educational session the post-test was applied to the caregivers in the experimental and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers who committed to providing care to their patients diagnosed with Stage II/III CRC and agreed to participate in the study, and who were suitable to respond to the forms in terms of cognitive and mental health were included in the study.

Exclusion Criteria:

* Caregivers whose patients had previously received chemotherapy for CRC or had colostomy in their patients and who had previously been education on the subject were excluded from the study
GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage. It is a leading cause of blindness in the United States, affecting 1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options including medications, laser treatment and surgical implants. The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open-angle glaucoma in the study eye
* Subject must be on 1 to 3 glaucoma medications
* Subject able and willing to attend follow up visits for two years postop
* Subject able and willing to sign informed consent

Exclusion Criteria:

* Pseudoexfoliative and pigmentary glaucoma
* Prior glaucoma surgery of any type