cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.

The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.

Following a screening visit, eligible subjects will be enrolled into the study. Eligibility will be decided depending on the level of SUI the patient has. Each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronical files.

Eligibility Criteria:
Inclusion Criteria:

* Negative urine culture.
* Positive cough test.
* Normal Papanicolaou (PAP) test from the past 3 years.

Exclusion Criteria:

* signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence.
* Overactive bladder.
* Previous bulking injections.
* Previous transvaginal mesh implant.
* Previous surgery for stress urinary incontinence.
* Presence of pelvic organ prolapse.
* Presence of an active or recurring genital infection or urinary tract infection.
* Previous laser-based or other energy-based treatments for gynecological indications.
* Vaginal bleeding of unknown reason.
* Pregnancy.
* Current pelvic floor physiotherapy.
* Current treatment with local or systemic hormone replacement therapy.
Patient and Physician Intervention to Increase Organ Donation

The number of persons on the national solid organ waiting list continues to increase while the number of donated organs has failed to keep pace. In some portions of northeastern Ohio the donation rate is as low as 32%. There is a positive association between discussing organ donation with a primary care physician and signing a donor card. However, such discussions are rare. The investigators propose a blinded randomized controlled trial to evaluate the effectiveness of two interventions: 1) showing a donation video to patients in primary care settings waiting to see their physician and 2) cueing of primary care providers to have donation discussions with their patients. The study will be conducted throughout Cuyahoga County in at least 10 ambulatory clinics associated with a single county medical system. Nine hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that patients exposed to the interventions will be 1) more likely to consent to donate organs, 2) more likely to have donation discussions with their primary care providers, and 3) equally satisfied with the time spent with their doctor compared to patients who are not exposed to the interventions.


Eligibility Criteria:
Inclusion Criteria:

* At least 2 visits with their primary care provider in the last 3 years
* Not previously consented to organ donation
* At least 15.5 years of age
* Less than 78 years of age

Exclusion Criteria:

* Visually impaired
* Cognitively impaired
* Non-English speaking
Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone

Hypotheses:

1. Preschool children with autism spectrum disorders (ASDs) who undergo ABA treatment only will demonstrate significantly better outcomes compared to an age and severity matched control group without ABA treatment.
2. Preschool children with ASDs who undergo ABA in combination with risperidone will demonstrate significantly better outcomes compared to age and severity matched children who are receiving ABA alone.
3. Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.
4. At baseline, children with ASDs will show significantly lower performances on measures of cognitive, neuropsychological, and socio-emotional functioning than age-matched typically developing controls.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism or severe pervasive developmental disorder (PDD) not otherwise specified (NOS) according to the Autism Diagnosis Interview-Revised (ADI-R)
* Aged 2.6 to 5.0.

Exclusion Criteria:

* Fragile X or metabolic etiology of PDD symptoms
* Diagnosis of other central nervous system (CNS) disorders
* Chronic serious medical problems
Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy

The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
* Agreement to maintain the same dose of metformin from randomization to the end of the study
* Age in the range of 18-78 years inclusive
* Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1
* HbA1c in the range of \> 7.0 to ≤10% at Visit 1
* Agreement to maintain prior diet and exercise habits during the full course of the study
* Ability to comply with all study requirements

Exclusion Criteria:

* Fasting Plasma Glucose (FPG) \> 270 mg/dl (15 mmol/L) at Visit 1
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Safety of Acupuncture for Functional Constipation

A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .

functional constipation,acupuncture,effects and safety,pragmatic RCT

Eligibility Criteria:
Inclusion Criteria:

* Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria
* Patients who are aged 18-75 years old
* Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials
* Sign the informed consent out of one's own will

Exclusion Criteria:

* Secondary constipation
* Patients with consciousness impairment, psychotic patients or patients unable to express clearly
* Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed
* Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases
* Women in pregnancy and lactation period
A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study

PC786 is a new medicine being developed for treatment of respiratory syncytial virus. The main purpose of this study is to evaluate the antiviral activity of PC786 in healthy adults infected with RSV virus in a viral challenge study.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health as determined by the Investigator based on medical history, physical examination, and routine laboratory tests at a screening evaluation.
* Male or female, aged between 18 and 55 years inclusive
* Body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 30kg/m2
* Subject must provide written informed consent
* Serosuitable to the challenge virus.

Exclusion Criteria:

* History or evidence of any clinically significant or currently active major clinical illness.
* Any significant abnormality altering the anatomy of the nose or nasopharynx
* Any nasal or sinus surgery within six months of the study
* Abnormal lung function
* Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test.
* Presence of cold like symptoms and/or fever on admission for the study
* History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks of the study
* History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C

Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load changes and liver tests change.


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C

Exclusion Criteria:

* HIV positivity
Probiotic Intervention for Stress and Cognition

The effect of probiotics on stress and cognitive function in healthy adults with moderate stress


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study and comply with its procedures.
* Be able to give written informed consent.
* Be between 21 and 50 years.
* Have moderate stress, as measured on Cohen's Perceived Stress Scale (PSS).
* Are not suffering from depression or anxiety, confirmed by a Hospital Anxiety and Depression Scale (HADS) score.
* Are not regularly consuming probiotics for at least 4 weeks prior to the Screening Visit.
* Is in general good health, as determined by the investigator.

Exclusion Criteria:

* Current diagnosis of currently active irritable bowel syndrome (IBS), according to Rome IV criteria.
* Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment.
* Known gluten intolerance, lactose intolerance, milk protein allergy.
* Intake of antibiotics within four weeks prior to the Screening Visit.
* Hypersensitivity to any of the ingredients in the Investigational Product (IP).
* Previous (within 5 years) or ongoing psychiatric illness.
* Consumption of systemic psychotropics, rheumatoid drugs, steroid drugs or creams containing cortisone.
* Regular consumption of asthma medications.
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk if participating in the study, or influence the results or the participant´s ability to participate in the study.
* Investigator considers the participant unlikely to comply with study procedures, restrictions, and requirements.
* Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function.
* Participation in other clinical trials involving Investigational Product consumption in the last month.
* Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial.
* Participants who are pregnant, breastfeeding, or wish to become pregnant during the study.
* Participants currently of childbearing potential, but not using an effective method of contraception.
* Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study.
* Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
* Taking any supplements or vitamins notably known to affect cognitive function. Vitamin D and calcium supplements permitted if on a stable dose for the previous 3 months.
* History of heavy caffeinated beverage consumption (\>400 mg caffeine/day) within past 2 weeks prior to the Screening Visit.
Peritoneal Closure Versus Non Closure During Open Appendectomy

There has been no consensus over closure versus non closure of peritoneum during abdominal operations. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.

There has been no consensus over closure versus non closure of peritoneum during abdominal operations. in literature, few reports suggested that peritoneal closure may prolong the operation time, may increase the costs and has a probable aggravating effect on postoperative pain. In addition, there have been some reports that suggest non closure of peritoneum may not increase the postoperative complications. The need of further studies to clarify the effect of peritoneal closure versus non closure on postoperative pain and life quality especially has been specified in some literature. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute appendicitis
* age between 18-65 years

Exclusion Criteria:

* preoperatively diagnosed intraabdominal abcess
* intraoperatively diagnosed free purulent fluid in abdominal cavity
* pregnancy
* malignancy history
* mental retardation
* chronical renal failure
* chronical liver disease
* diabetes mellitus
* patients' denial of participation to study
Single Site Versus Multi Site Robotic Hysterectomy

Robotic single site surgery (R-SSH) is a novel technique, which may be superior to multi site hysterectomy (R-MSH) in select patients regarding cosmesis and postoperative pain. A randomized trial is performed to compare R-SSH with R-MSH with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

The study is scheduled to start November 2018 and compares robotic single site to multi site hysterectomy. Procedures are performed on two locations, Herning and Herlev Hospitals, by experienced surgeons. Patients are randomized to either R-SSH (No.=62) or R-MSH (No.=62). Patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and Body Image Questionnaire and photo-evaluations.

Postoperative pain and split times spent at the operation theatre will be registered as secondary outcome parameters.

A follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. Interviews and diaries will include time of return to home and work, daily activities including sexuality The R-SSH is performed using da Vinci, Xi robotic system. One single port, diameter 2 cm is applied. Applying an additional assistant port is defined conversion of procedure R-MSH is performed using standard equipment and 4 trocars, 5 mm each.

Sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. To include those not working, the calculation was performed with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group and suggested that the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. All calculation are based on two-sided testing with alpha of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Hysterectomy on benign indication,
* American Society of Anesthetists group 1 or 2,
* BMI less than 30 kg/m2
* uterine size less than 300 g estimated by ultrasound, using Ferraris formula.

Exclusion Criteria:

* adhesions
* prior extensive abdominal surgery
* prior midline incision
* cutis laxa of abdomen surgery
* endometriosis
* more than 1 cesarean section
* malignant disease
Assessment of the Wide Field of View Provided by the SurroundScope

The aim of this study is to assess the need and potential benefits of the wide field of view during general and gynecology laparoscopic surgery.

The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope.

270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will evaluate standard laparoscopic surgery using the 270Surgical system; "The SurroundScope".

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18
2. Capable of giving informed consent
3. Scheduled for general or gynecology laparoscopic surgery or open procedure that in the surgeon's opinion can be performed laparoscopically with the 270System

Exclusion Criteria:

1. Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
2. Patients with contraindications to undergo surgery
3. Patients with ASA class\* \>3
4. Advanced cirrhosis with failure of hepatic function
5. Patients who have participated in another interventional clinical study in the last month
6. Pregnancy
7. Unable to consent (due to cultural, language or neurological barriers)
Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India

The purpose of this study is to evaluate a pilot peer support intervention, entitled "Kanasina Gulabi" (Translation "My Dream Rose" in Kannada), designed to improve quality of life and diabetes management among young adults living with type 2 diabetes. The intervention, delivered by non-specialist providers - trained young adult peer navigators who are also managing type 2 diabetes - is expected to improve physical and mental health outcomes among participants. The sample includes young adults aged 18-40 with a diagnosis of type 2 diabetes in Mysore district, South India. Participants were quasi-randomly allocated to the intervention or control group. With the support of their peer navigators, intervention participants will develop action plans to improve their physical and mental health outcomes. This study plans to assess the feasibility, acceptability, and preliminary effectiveness of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 - 40 years old
* self-reported to have type 2 diabetes
* living in Mysore district
* able to speak English or Kannada
* and able to access a cellular phone during the study period

Exclusion Criteria:

* pregnant
* living with a serious medical or psychological disorder that would impede study procedure
Captain Sonar Impact on Trauma Patient Management

Trauma patient care requires collaboration and interaction with close relationship between many stakeholders from different professions (senior doctor, intern, nurse, nurse helpers, surgeons, etc).

This is a stressful situation where decision and action need to be quick, decisive and coordinate.

In this situation, quality of care and patient safety depends on a good interprofessional communication.

The acquisition of advanced communication skills, team management and leadership, stress management are essentials elements in the practice of Intensive and trauma care. However, advanced structured training or assessment of theses skills is lacking in medical education or Healthcare professionals training. The study therefore, aimed to develop a global and attractive training to help healthcare professionals to improve their skills.

Captain SonarTM is a naval battle game where two teams each composed of four participants clash. Each player has a well-defined role and it is imperative to communicate in a closed loop to advance in the game. This game also includes components similar to support for shock management: stress, speed of action, central communication and teamwork of four protagonists (Team Leader-Captain, intern-Second, nurse-Mechanic, Nurse help-Detector). It may improve team building, team leadership, interprofessional work, communication, stress management. The study hypothesis is that this board game would have an impact on the performance of professionals when facing a multiple trauma simulated patient. (differences in terms of technical and non-technical performance. Different use of closed loop communication, Different stress management, different efficiency and interprofessional collaboration with potentially a reduction in the timing of treatment being delivered in trauma room)

All the teams of 4 participants and 1 medical Student previously trained will then benefit from a training session either exposed to captain sonar or into the control arm with monopoly.

High-fidelity and multiprofessional simulation session based on the incoming of a severe traumatized patient will be held. These sessions will take place on high-fidelity mannequins lent by the CLESS (Lyonnais Center for Health Simulation Education) in pavilion H of Édouard Herriot Hospital, within the Trauma Center (in situ).

The same scenario will be presented for all groups (exposed and controls) with the same objectives of realization and the same complexity. An audio-visual recording will take place during each session in order to allow the evaluation of the study criteria on technical and non technical skills between the participants a posteriori of the simulation session.

Eligibility Criteria:
Inclusion Criteria:

Professional working at the Unit

Exclusion Criteria:

None