cyrilzakka/clinical-trials huggingface dataset:
SEE Change Evaluation - Impacts of Personal Agency Training on Ugandan Entrepreneurs

This study is proposed as an individually randomized control trial (RCT) designed to assess the short-term impacts (follow up at six months) of a personal agency training on a range of economic and health outcomes for micro and small entrepreneurs in Western and Central Uganda. Participants will be randomly selected and assigned to either the intervention group (n=400) or wait-listed control group (n=400). The intervention will include the standard Empowered Entrepreneur training curriculum which includes personal agency alongside basic business training that has been developed by the SEE Change team. This training will take place over three consecutive days (approximately 25 hours of content).

The investigators propose to examine the comparative impacts of a personal agency and business training curricula on outcome measures focused in three areas 1) business related outcomes; 2) personal agency and flourishing; and 3) social spillover impacts.

Aim 1: Assess changes in business related outcomes including improved sales and profit, enhanced business skills and behaviors, and business-related goal setting.

Aim 2: Assess changes in personal agency and flourishing as determined through personal goal setting and psychometric measurements of self-esteem, self-confidence, grit and flourishing.

Aim 3: Assess social spillover impacts of the training on depression, anxiety and stress, and changes in gender norms and attitudes.

Eligibility Criteria:
Inclusion Criteria:

* Small or micro entrepreneur;
* Business has been in operation/existence for at least the past 12 months;
* Entrepreneur is between the ages of 18 and 55;
* Entrepreneur has the ability to participate in all training activities;
* Informed consent is obtained from the entrepreneur;
* The entrepreneur is not planning to leave the area in the next 12 months;
* The entrepreneur has access to a phone for contact purposes;

Exclusion Criteria:

* Entrepreneur is unable to provide informed consent or informed consent is not obtained;
* Entrepreneur is not considered a small or micro entrepreneur;
* Entrepreneur is younger than 18 years of age;
* Business has been in operation/existence for less than 12 months;
* Entrepreneur's primary business is farming (anything related to seasonal crop production);
* Entrepreneur is planning to leave the area in the next 12 months;
Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant

The aim of this study was to investigate the simply use of three-dimensional (3D) printed individualized porous implants in the absence of autogenous/allogeneic bone graft or any osteoinductive agents to treat the large bone defects caused by varies of pathogenesis and systematically study its long-term therapeutic effect and osseointegration characteristics.

A selection of fifty-eight patients with large bone defects caused by tumor, infection or trauma received the individualized porous implants treatment, and two typical cases were chosen for detailed study. Further, the large segmental femur defect model of sheep was utilized to study the osseointegration characteristics of the individualized porous implants in 1, 3, 6 months after implantation.

Eligibility Criteria:
Inclusion Criteria:

* Large bone defects (\>4cm) in spine, limb bone and hip joint caused by tumor, infection or other pathogenesis received the individualized porous implants treatment.Exclusion Criteria:
* Bone defects less than 4cm long.
* Bone defects treated by other methods ,such as ilizarov technique, masquelet technique or Ti mesh.
The Use of MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis

OBJECTIVES :

1. To investigate the expression pattern of miRNAs operational in inflammation, angiogenesis, hypoxia, apoptosis and cell proliferation in eutopic and ectopic endometrium of patients with endometriosis and normal endometrium of healthy controls.
2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways.
3. Evaluation of significant outcome of objective 1 in serum samples to establish them as biomarkers.

Study Design:

Case control study. sample size: 200

METHODOLOGY :

1 Investigator will take Both blood and tissue samples used to study them. 2. Investigator will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (Surgical profile) before their planned surgery.

3.Small tissue samples will be taken from the tissue which is surgically excised as a part of treatment.

4. It will include tissue from inner lining of uterus (endometrium) in all participants and from excised endometriosis tissue in patients with endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients having more severe forms of endometriosis (Stage III and IV)
* The probands were chosen randomly from the pool of available endometriosis patients and healthy controls of Indian origin.

Exclusion Criteria:

* Diagnosis of non-endometriotic ovarian cysts, adenomyosis, ovarian cancer, fibroids, and stage I and II endometriosis.
* Exclusion criteria defined for the control group were personal history of chronic pelvic pain, secondary dysmenorrhea, abnormal uterine bleeding and family history of endometriosis.
Bronchial Alpha Amylase as a Marker for Early Aspiration Pneumonia in Therapeutic Hypothermia.

Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in patients successfully resuscitated after out-of-hospital cardiac arrest.

In this prospective non interventional study we included patients resuscitated after cardiac arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar lavage using specific display (Combi-Cath) was executed immediately after admission for each patient with both biochemic and bacteriological analysis including dosage of bronchial salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and biological criteria. On this basis we intended to determine a threshold measure of alpha amylase predicting occurrence of aspiration pneumonia and allowing a guidance in antibiotherapy prescription. Sensibility and Specificity of this technique were determined.


Eligibility Criteria:
Inclusion Criteria:

* Well resuscitated patients after out-of-hospital cardiac arrest
* Indication of Therapeutic Temperature Management
* Patients aged over 18 years
* Immediate or deferred acceptation of study

Exclusion Criteria:

* Patients aged under 18 years.
* Pregnant women.
* Against indication to therapeutic hypothermia.
* Active therapeutic limitation after admission.
* Patient without social security.
Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches

This project (CO-OP II) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (CP). The initial study was comprised of a series of four single case studies with children with CP. It evaluated the potential of the Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children with CP and tested the procedures for CO-OP II. The overall objective of the full series of studies is to determine whether better functional outcomes are achieved for children with CP with CO-OP intervention than with contemporary occupational therapy treatment.

The primary objective of CO-OP II is to establish the feasibility of conducting a full scale randomize control trial (RCT) to discover if there are differences in functional outcomes (i.e., improvement in task performance, self efficacy) between a group of children with CP receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In order to meet this objective, a pilot RCT will be conducted to answer the specific research questions outlined below:

1. Do children wiht CP acquire the skills they set as goals in each of the two treatment groups?
2. Do the acquired skills generalize and transfer?
3. Are the skills maintained at 4 months post intervention?
4. Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy than the CTA?
5. Does amount of parent involvement have any effect on skill acquisition or self efficacy?

Completion of this pilot RCT will provide the necessary data to conduct a full study to test the following hypothesis:

- Children with CP who receive CO-OP treatment will be more successful than children receiving CTA in improving their performance on child-chosen skills and they self efficacy.


Eligibility Criteria:
Inclusion Criteria:

* between 7 and 12 years of age
* diagnosis of cerebral palsy with hemiplegia or spastic diplegia
* Level 1,2 or 3 on the Gross Motor Function Classification Scale(GMFCS)
* normal intelligence (IQ\> 85 on at least one scale (verbal or performance) of the Kaufman Brief Intelligence Test (KBIT-2)
* child assent and agreement to participate
* parental consent and agreement to participate
* sufficient language ability to communicate with and be understood during treatment

Exclusion Criteria:

* previously received or presently receiving a cognitive treatment for motor-based performance problems
* use of alternative communication system such as PECS or communication board
* regular use of BOTOX during intervention period
Drug Intervention of Spontaneous Hyperventilation in Patients With Aneurysmal Subarachnoid Hemorrhage

Although spontaneous hyperventilation patients with aneurysmal subarachnoid hemorrhage closely associated with poor outcomes, the standard therapy remains unavailable. Remifentanil has the pharmacological characterization of respiratory inhibition, mainly prolonging the expiratory time and decreasing the respiratory rate while preserving the respiratory drive. The investigators hypothesis that spontaneous hyperventilation could be corrected by titrating the dose of remifentanil and cerebral blood flow will augment during this process.

Evidence has shown a high incidence of spontaneous hyperventilation in patients with aneurysmal subarachnoid hemorrhage (aSAH), which is associated with poor outcomes. It's well established that the hypocapnia caused by hyperventilation leads to cerebral vasoconstriction, reduces the cerebral blood flow, and decreases the cerebral blood volume and intracranial pressure consequently. However, persistent cerebral vascular constriction increases the risk of cerebral ischemia; therefore, maintaining a partial pressure of arterial carbon dioxide (PaCO2) in the range of 35-40mmHg is recommended to minimize the hazard hypocapnia.

There's still no standard method to deal with spontaneous hyperventilation. Based on the pharmacology and clinical experience, remifentanil seems to be an ideal choice since it could inhibit the respiratory rate in a dose-dependent fashion. As one of the most used short-acting opioids, remifentanil could prolong the expiratory time, meanwhile not influencing the inspiratory time and respiratory drive, consequently decreasing respiratory rate and maintaining the tidal volume.

In this exploratory physiology study, the investigators will test the hypothesis that spontaneous hyperventilation could be suppressed by titrating the dose of remifentanil and could be realized as the target of PaCO2. The investigators will determine the optimal amount of remifentanil, which fulfills the criteria of efficacy and safety, and evaluate its effect on the cerebral blood flow velocity of both the middle cerebral artery and internal carotid artery.

Eligibility Criteria:
Inclusion Criteria:

* Aneurysmal subarachnoid hemorrhage, after craniotomy or clipping
* Arterial blood gas satisfy with PaCO2\<35mmHg and pH\>7.45
* Presence of an endotracheal tube
* Assisted ventilation mode,CPAP/PSV
* ICP monitoring

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Chronic obstructive pulmonary disease
* Allergy to opioids
* Clinically relevant hepatic or renal failure
* Hemodynamic instability
* TCD windows cannot detect cerebral blood flow
* Refuse to participate the study
Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes

The purpose of this study is evaluate the effectiveness of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to support adults in Southeast Minnesota (Mower, Freeborn, and Olmsted counties) and Northwest Wisconsin (Barron, Rusk, and Dunn) who have uncontrolled diabetes (HbA1c ≥ 9%) and have experienced an emergency department (ED) visit or hospitalization for any cause in the prior 6 months.


Eligibility Criteria:
Inclusion Criteria (Patients):

* Most recent hemoglobin A1c ≥ 9% within the last 2 years.
* Age ≥ 18 years old.
* Type 1 or type 2 diabetes.
* Paneled to a Mayo Clinic or Mayo Clinic Health System practice.
* Able to provide informed consent.
* Proficient in English.
* Community-dwelling.
* Live in Southeast Minnesota (Mower, Freeborn, or Olmsted counties) or Northwest Wisconsin (Barron, Rusk, or Dunn counties).

Inclusion Criteria (Paramedics):

•Community Paramedics who delivered the Diabetes-REM intervention.

Exclusion Criteria:

* Cognitive impairment precluding informed consent.
* Lack of conversational English skills.
* Resident of a long-term care facility.
* Enrolled in hospice.
* Enrolled in a care coordination or disease management program.
* Advanced or terminal illness.
Psychological Prevention of Internalizing Disorders

The purpose of this study is to determine whether cognitive-behavioral group prevention (CBT-G) for german children is effective and to what extent parental group training moderates outcome.

Internalizing disorders represent a large group of psychological disorders among children who are referred to psychological treatment. Anxiety, Depression and somatoform disorders in children and adolescents increase the risk of mental disorders in adulthood. Some english programs have proved the efficacy of CBT-G prevention.This study will test the efficacy of CBT-G in German children. The role of parental involvement is currently subject to scientific discussions. The impact of an additional parent-group training will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* age 8- 12 years and
* anxiety symptoms and/or
* depressive symptoms and/or
* somatoform symptoms

Exclusion Criteria:

* psychiatric disorder according to ICD-10/ DSM-IV-TR requiring individual psychotherapy
* IQ \< 85
RAS Quantification in Patients With Aliskiren or Candesartan

Forced blockade of the renin-angiotensin-system (RAS) by using direct renin inhibition (DRI) has long been propagated to effectuate beneficial outcomes. However, recent large clinical trials have outlined harmful effects for DRI in combination with other forms of RAS blockade. To date, information regarding DRI as RAS-blocking monotherapy is very limited. Furthermore, it remains to be elucidated how DRI and angiotensin receptor blockers affect the so-called 'classical' and 'alternative' RAS molecularly. As components of the 'alternative' RAS (e.g. Ang 1-7) have moved into research focus, it would be of importance to determine angiotensin regulation with medical RAS blockade.

In this prospective, single-center randomized trial over 10 weeks, 24 patients with chronic kidney disease (CKD) stage III-IV (eGFR 15-59 ml/min) will be randomized to take either aliskiren (up to 300 mg per day) or candesartan (up to 16 mg per day) after a two week run-in phase where all RAS-blockers are eliminated. The investigators will then employ a novel mass spectrometry-based quantification method (after run-in and 10 weeks) to capture the concentrations of ten different angiotensin peptides (including angiotensin I and II, angiotensin 1-7 and angiotensin 1-5).

The investigators hypothesize that significant differences exist between angiotensin levels in CKD patients with DRI compared to angiotensin receptor blockers. Specifically, the investigators expect to determine the regulation of the alternative RAS represented by angiotensin 1-7 with proximal versus distal blockade of the system.

Our data might contribute to a more profound understanding of results from registries and clinical trials beyond the clinical effects of RAS blockade. Further, the study's results might help to individualize and optimize RAS-blocking therapy strategies in CKD patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stages III-IV (defined by modification of diet in renal disease (MDRD) formula)
* Urinary albumin to creatinine ratio (UACR) \>300mg/g, UACR \>200mg/g if already receiving RAS blockade
* Arterial hypertension

Exclusion Criteria:

* Age \<18 years
* Diabetes mellitus type 2 (defined by WHO criteria)
* Chronic kidney disease stage V (end-stage renal disease)
* UACR \>3500mg/g
* Severe hypertension (systolic blood pressure \>180mmHg)
* Pregnancy
A Study of Gender-specific Impact Factors on Elderly Disability and Cognitive Impairment

Elderly disability and cognitive impairment rates were different between elderly man and woman. Sex-specific risk factors and observed gender differences across the lifespan were associated with different degrees of cognitive and activity of daily living function decline between men and women. However, some of these viewpoint remains controversial.

The aim of this study is to explore the gender differences and influencing factors of disability and cognitive impairment among the elderly.

With the rapid increase in the aging population in China, age-related cognitive impairment and disability has become a pressing public health concern. A number of large-scale studies in China and abroad have shown that the average life expectancy of women elderly is higher than men, but the rates of disability and cognitive impairment are higher. However, it is lack of exploration of the factors associated with the gender-specific of disability and cognitive impairment.

The aim of this study is to explore the gender differences and influencing factors of disability and cognitive impairment among the elderly. A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to collect data. And the data from the China Longitudinal Healthy Longevity Survey (CLHLS) was used to further validate the results.

Eligibility Criteria:
Inclusion Criteria:

1.The elderly aged 65 and above.

Exclusion Criteria:

1. Lack of diagnostic information.
2. Missing key influencing factors such as gender and age.
3. Hearing or linguistic impairment.
4. Comatose patients.
Parent/Caregiver Conference Attendance Feasibility

This study will assess and evaluate conference attendance feasibility and will gather feedback about preferences and barriers to attendance at the American Society for Nutrition annual conference.

This study will use a survey provided on the American Society for Nutrition Family Support Grant application webpage for those who are registering to attend the American Society for Nutrition annual meeting and who are applying for this particular grant. The survey will take about 10 minutes to complete and will provide detailed information for assessment and evaluation of conference attendance feasibility and will also provide feedback about preferences and barriers related to attendance and this annual meeting.

Eligibility Criteria:
Inclusion Criteria:

* Must be an applicant for the Family Support Grant to the American Society for Nutrition annual conference that takes place in June 2018

Exclusion Criteria:

-
Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)

This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.

This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL powers.
* Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
* Able and willing to return for scheduled follow-up examinations after surgery.
* Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Insulin-dependent diabetes or diabetic retinopathy.
* History of previous ocular surgery.
* Cataract of any grade.
* Monocular.
* Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
* Other protocol-specified exclusion criteria may apply.
GlutDigest - Pilot Study

This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures and protocols before the full-scale, crossover study is conducted.

Two important factors can influence the proportions of gluten and starch that resist digestion: (1) enzyme availability and specificity and (2) the structural properties of the food. A complete evaluation of gluten digestion and of the impact of dietary supplements is difficult to conduct because it is not easy to obtain samples of digestive chime. The analysis of the ileal effluent of healthy ileostomy patients constitutes a non-invasive alternative to intubation techniques for the study of nutrient digestion and of the fate of probiotics in the small intestine.

The main aim of this study is to test and optimize sample analysis protocols before conducting the full-scale, crossover study which will aim at evaluating the impact of two dietary supplements (Glutalytic® and DE111®) and of oatmeal properties on the digestion of gluten and starch and on the glycemic response.

Eligibility Criteria:
Inclusion Criteria:

* Subject has given written informed consent
* Subject has an ileostomy stable for at least 3 months post-operative and shows normal stoma functions
* Subject is otherwise healthy
* Subject is available to participate in the study sessions on the proposed dates

Exclusion Criteria:

* Subject has coeliac disease or allergy to wheat products and/or any other ingredients in the test meal and standard meals
* Case of obstruction of the stoma in the past 3 months
* Body mass index \< 18 kg/m2 or \> 30 kg/m2.
* Diagnosed mouth, throat or active gastrointestinal pathology (other than ileostomy) that may affect normal ingestion and digestion of food.
* History of pancreatic disease
* Subject is immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last year)
* Subject has Type 1 or Type 2 diabetes mellitus.
* Subject has a history of bariatric surgery.
* Subject has a history of drug and/or alcohol abuse at the time of enrolment
* Subject is currently participating in another study, or plans to participate in another study during the study period
* Women of child-bearing potential who do not use an acceptable method of contraception
* Pregnant or nursing (lactating) women