cyrilzakka/clinical-trials huggingface dataset:
Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency

Female patients with POP will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the POP. Surgical repair will be performed by a single surgeon who will perform either a laparoscopic or vaginal repair.

Patients will be recruited and sign a consent form. The patients included are patients with POP that are candidates for either laparoscopic or vaginal repair.

Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* The day of surgery before surgery.
* The day after surgery.
* 3 months post-operational. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Eligibility Criteria:
Inclusion Criteria:

* Any woman undergoing POP repair

Exclusion Criteria:

* Women above or below the age limit
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

The aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
* Written informed consent

Exclusion Criteria:

* Persons with impaired decision-making ability.
* Pregnant women or who are actively trying to conceive.
* Additional eye disease affecting the macula or posterior retina.
* Creatinine clearance \< 50 ml/min
* Hyperkalemia \> 5 mmol/l
* Serum creatinine \> 2 mg/dl in men or \> 1.8 mg/dl in women
* Treatment with potassium sparing agents or potassium
* Treatment with any other drugs known to cause interaction with eplerenone
* Microalbuminuria in patients with type 2 diabetes
Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Participant had given written informed consent to participate in the study in accordance with local regulations.
* Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus (T1D) made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).
* At the Screening Visit, A1C had to be between 7.0% and 10.0%.
* Females of childbearing potential had to use an adequate method of contraception and have a negative pregnancy test.

Exclusion Criteria:

* Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.
Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery

To study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification.

Cataract surgery facilitates improved visual acuity through extraction of an opacified lens, followed by intraocular lens implantation. An average adult cornea has 2000 to 2500 cells/mm2, a count that diminishes with age with a rate of attrition of approximately 0.3% to 0.5% per year. Long-term postoperative corneal transparency depends on the morphological stability and functional integrity of the corneal endothelium. It is well established that all surgical interventions that require entry into the anterior chamber result in some damage to the corneal endothelium.

Endothelial cell loss results in cell hypertrophy to maintain continuity, resulting in a change in endothelium cell density and morphology. Many studies have assessed the impact of various surgical techniques on endothelial damage and numerous studies have investigated the factors influencing endothelial cell loss after phacoemulsification. The goal of this study is to investigate the correlation of postoperative corneal edema with the reduction of endothelial corneal cell density after phacoemulsification.

Eligibility Criteria:
Inclusion Criteria:

* The presence of senile cataract with equivalent grades and a history of visual acuity regression

Exclusion Criteria:

* Patient with total white cataract
* With history of ocular surgery
* With other eye diseases (corneal pathology, Fuchs dystrophy, uveitis and glaucoma) or systemic diseases (diabetic disorder and dementia)
Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care

Early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some complication rates. However, in patients with multiple injuries, the optimal treatment of skeletal trauma may be affected by severe injury to the head, chest, or abdomen. The relationship between associated injury severity and the timing of definitive management of unstable fractures is not well-understood. The practice of "early total care," early definitive fracture management, has been criticized by some, who have suggested that additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory response. The alternative extreme of "damage control orthopedics (DCO)" has been recently proposed as a means of providing provisional stability of major skeletal injury, generally through external fixation. It is speculated that DCO will diminish the potential for systemic compromise. However, the need for further (definitive) surgery on a delayed basis, and the potential additional complications and costs associated with this strategy are controversial. The investigators' goals are to define which injuries or parameters warrant delay of definitive orthopaedic care, and to determine what time interval for fracture fixation promotes optimal patient outcome. The investigators will assess the effects of fracture fixation on head injury, chest injury, abdominal injury, mortality, complications, patient outcomes, and costs.


Eligibility Criteria:
Inclusion Criteria:

* All patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries:

  * unstable pelvic ring fracture
  * unstable acetabulum fracture, or
  * femur fracture
* Patients will be included regardless of race or gender. Isolated fractures will be included

Exclusion Criteria:

* Low-energy pelvis and hip fractures will be excluded
* Patients younger than 16 years of age will be excluded
Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy

This study is being conducted to collect information from subjects with osteoporosis regarding their experience using the Forteo B Pen to self-administer teriparatide in the community setting. Information collected during this study will be used to assess the need for changes to the Forteo B-Pen User Manual and patient educational tools. Additionally, the information generated from patients during this trial will be reviewed to assess the acceptability of the Forteo B Pen for commercial launch.


Eligibility Criteria:
Inclusion Criteria:

1. Men with primary or hypogonadal osteoporosis or postmenopausal women with osteoporosis in the opinion of the investigator. Subjects must be at high risk for fracture in the opinion of the investigator.
2. Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel.
3. Able to read, understand, and respond to self-administered questionnaires.
4. Without language barrier, cooperative, and expected to return for all follow-up procedures.
5. Have provided written informed consent to participate in this study, according to local regulations after being informed of the risks, medications, and procedures to be used in the study.

   Exclusion Criteria:
6. Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator.
7. Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator.
8. Subjects who have an increased baseline risk of osteosarcoma, including those with: Paget's disease of the bone or unexplained elevations of alkaline phosphatase, children and young adults with open epiphyses, and subjects who have received external beam or implant radiation therapy involving the skeleton.
9. History of malignant neoplasms in the 5 years prior to study entry, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated, or history of carcinoma in situ of the cervix or uterus.
Seprafilm® for Prevention of Adhesions at Repeat Cesarean

Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.

This is a prospective randomized double-blinded study. Patients will be randomized prior to primary cesarean section to either the study arm (Seprafilm® placement) or control arm (nothing placed). Seprafilm® will be placed over the repaired uterine incision and over the anterior aspect of the uterus prior to closure of the fascia (2 to 3 sheets per patient). Randomization will be by opaque envelops containing group assignment.

Participants and surgeons will be blinded to group designation at the time of repeat cesarean. The surgeon will be asked to grade the adhesions at the time of repeat cesarean.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women after 24 weeks' gestation.
2. First cesarean delivery.
3. Age \> 18 years.
4. Cesarean to be performed by a participating surgeon.
5. Non-closure of the visceral or parietal peritoneum.

Exclusion Criteria:

1. Any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery.
2. Clinical diagnosis of chorioamnionitis.
3. Women having tubal ligation at the time of primary cesarean.
4. Inability to obtain informed consent.
Comparison of Two Spinal Needles Regarding Postdural Puncture Headache

The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.

Two kind of spinal anesthesia needles will be used:

1. 26 Gauge Quincke (cutting-tip needle)
2. 26 Gauge Atraucan (atraumatic needle)

The investigators will observe:

1. Number of spinal punctures
2. Time required for the spinal anesthesia procedure

Patients will be evaluated after 7 days for:

1. Headache
2. Backache

It is a known phenomenon that spinal anesthesia sometimes results in headache.

The aim of the study is to observe the rate of postdural puncture headache observed after spinal anesthesia in cesarean section patients.

Two kind of spinal anesthesia needles will be used:

1. 26 Gauge Quincke (cutting-tip needle)
2. 26 Gauge Atraucan (atraumatic needle)

We will observe:

1. Number of spinal punctures
2. Time required for the spinal anesthesia procedure

Patients will be evaluated after 7 days for:

1. Headache
2. Backache

2 kind of spinal anesthesia needles will be used, but no comparison will be made. This is an observational study. Although literature gives different rates of postdural puncture headache for these two needles, we observe the same rate of headache in our clinical practice. We want to define the real rate of postdural puncture headache in patients undergoing cesarean section with spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant female patients between 18-40 years old undergoing cesarean section
* Patient accepting spinal anesthesia

Exclusion Criteria:

* Infection at the spinal needle insertion cite
* Coagulability disorder
* Patient not accepting the procedure
Post Critical Illness Dysphagia in the Intensive Care Unit

The aims of the study are to determine: 1) the prevalence of ICU acquired dysphagia, 2) identify risk factors for ICU Acquired dysphagia, and 3) consequences of ICU acquired dysphagia including: ICU mortality, hospital mortality, days of mechanical ventilation, ICU length of stay, hospital length of stay, post extubation aspiration pneumonia, and rate of percutaneous endoscopic gastrostomy placed feeding tube (PEG-Tube) insertion, and/or total parenteral nutrition (TPN) and/or Dobhoff feeds.

The RC will collect daily data on the use of advance life support, need for mechanical ventilation and outcomes (mortality, duration of mechanical ventilation, ICU length of stay, hospital length of stay). Enrolled patients will undergo a water sip test in the ICU and a videofluroscopic swallowing study (VFSS) performed by a registered speech-language pathologist (SLP). A VFSS is a videotaped or digitized dynamic fluoroscopic image that focuses on the oral, pharyngeal, laryngeal and upper esophageal swallow physiology. Patients will then be followed as two cohorts 1) patients that have dysphagia (or abnormal test) based on the VFSS, and 2) patients who have normal VFSS. We will then prospectively follow these two groups of patients during hospital stay censored at 30 days.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years of age and older)
2. Received mechanically ventilated for \> 24 hours
3. Have been extubated for \>24 hours
4. Hemodynamically stable (i.e. not requiring active resuscitation or vasoactive agents)
5. Able to participate in VFSS - with n the first 7 days after successful extubation. (+/- 2 days)

Exclusion Criteria:

1. Gastrostomy tube or a Gastro-jejunostomy tubes
2. Current contraindication to oral feeding (eg. recent gastrointestinal surgeries as indicated by their surgeons)
3. Being actively palliated
4. Tracheostomy
5. Neuromuscular condition associated with dysphagia: (e.g., amyotrophic lateral sclerosis, myasthenia gravis)
6. Pre-existing history of dysphagia
7. Ongoing respiratory support (defined as requiring ≥ 50% oxygen, bi-level positive airway pressure, or high flow nasal cannula) for 7 days or more after extubation.
8. Caring physician declined
A Prospective Longitudinal Study in Adults with Multifocal Motor Neuropathy

This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy over time and collect data on their clinical outcomes, quality of life, and use of health care resources. Participants will follow their regular visit schedule with their treating physician, except for an optional second visit occurring 7 to 14 days after the start of the study to collect biomarker data. No IMP will be administered.


Eligibility Criteria:
Inclusion Criteria:

* Is at least the local legal age of consent for clinical studies when signing the ICF
* Is capable of providing signed informed consent and complying with protocol requirements
* Has an existing or new diagnosis of MMN made by a neuromuscular specialist or neurologist

Exclusion Criteria:

* Is currently participating in any clinical study with an IMP
* Has other medical conditions that could affect the assessment of MMN
A DDI Study of JMKX000623 and Metformin Hydrochloride

A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.

The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Chinese subjects aged 18-45 years, male or female;
2. Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI\<27.0 kg/m2;
3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;
4. Able to provide written informed consent voluntarily.

Exclusion Criteria:

1. Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;
2. History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;
3. Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;
4. Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;
5. Other conditions unsuitable for the study confirmed by the investigator.
A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA)

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form and an informed assent, if applicable
* Be between the ages of 12 to 75 years
* Have had a history of moderate to severe asthma for at least one year prior to screening
* Have had treatment with a stable regimen of of salmeterol 50 µg twice a day (BID) or formoterol 12 µg BID for at least 8 weeks prior to screening
* Have had treatment with a stable regimen of high-dose inhaled corticosteroids (ICS) for at least 8 weeks prior to screening
* Have inadequately controlled asthma
* Have had at least one asthma exacerbation requiring systemic corticosteroid rescue in the 12 months prior to the screening visit while receiving treatment with high-dose ICS
* Have less than 10 pack-years smoking history
* Have a positive skin test for or a positive, in vitro response to one relevant perennial aeroallergen documented within the 12 months prior to screening
* If a subject has not had a positive skin test or in vitro reactivity in the 12 months prior to screening, the subject must demonstrate a positive response to at least one relevant perennial aeroallergen in a skin or in vitro test prior to randomization
* Female subjects of childbearing potential must use an effective method of contraception from screening through their duration of participation in the study
* For the collection of additional blood samples for future research (optional), provide signed consent and an informed assent, if applicable.

Exclusion Criteria:

* Have had an asthma exacerbation requiring intubation within 12 months prior to screening
* Have active lung disease other than asthma
* Have had an asthma exacerbation requiring treatment with the addition of systemic (oral or intravenous) corticosteroids or an increase in systemic corticosteroids within 30 days prior to screening
* Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.
* Have significant medical illness other than asthma
* Have taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics, within 3 months prior to screening
* Have taken other investigational drugs within 30 days prior to screening
* Have been treated with Xolair within the 12 months prior to screening
* Have a history of drug or alcohol abuse that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study
* Have elevated serum IgE levels for reasons other than allergy
* Are pregnant or lactating
Enhancing Social Interaction With an AlterEgo Artificial Agent

The objective of AlterEgo is the creation of an interactive cognitive architecture, implementable in various artificial agents, allowing a continuous interaction with patients suffering from social disorders, by virtue of changes in behavioural (robot-based) as well as morphological (avatar-based) properties of that agent. The project includes research in fundamental and clinical neurosciences, interaction modeling, development of new computer-vision techniques and human-robot interfaces, as well as evaluation of the scenarios with patients before, during, and after training sessions. At the end of the project, the investigators will produce a new avatar-based clinical method able to enhance social interaction of patients.

The first challenge of this project is to create an avatar alter ego of a patient. Based on recent work in social robotics and neurosciences, the investigators hypothesize that if patients face artificial agents morphologically and behaviourally similar to them, they will increase their social interaction. The second challenge is to transform the morphology and the behaviour of the similar artificial agent into that of a healthy and different agent. The investigators assume that the smooth and continuous behavioural shift from similar/unhealthy to complementary/healthy social behaviour will lead to a better social rehabilitation. AlterEgo opens the door to a new generation of social artificial agents in service robotics. AlterEgo is an interdisciplinary project at the interaction of Social Motor Neurosciences (UM1), Robotics (EPFL), Complex Systems Dynamics (UOB), Computer Vision (DFKI), and Psychiatry (CHU).

This project includes a set of experiments that started in april 2014 and will terminate in september 2016 before undergoing a randomised clinical research.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from schizophrenia according to the criteria proposed in the DSM-IV-TR
* Aged between 18 and 60 years old.

Exclusion Criteria:

* History of head trauma
* History of neurological disorders (epilepsy disease, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Huntington's disease, stroke)
* An actual ECT treatment
* Substance Abuse and / or current Substance dependence (excluding tobacco and cannabis).
* Pregnant women, new mothers and nursing mothers
* People private of their liberty