cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease

The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.


Eligibility Criteria:
Inclusion Criteria:

* Have signed a written informed consent voluntarily, prior to the any procedure
* Degenerative disc disease patients of aged over 20 years
* Have one or more of the symptomatic lumbar level(L1\~S1) as confirmed using radiology(X-ray, MRI and/or discogram/CT)
* Have been diagnosed 2\~3 degree of MRI index by modified thompson classification
* Oswestry diability index(ODI) of 30 or greater
* Visual analog scale(VAS) of 4 or greater

Exclusion Criteria:

* Subjects unable to have radiological examination
* Have history of neurological disease, herniated lumbar disc, compression fractures and lumbar spinal surgery
* Sacroiliac joint dysfunction
* Have been treated with any drugs for pain control within 7 days prior to the first administration
* Hypersensitivity to drugs
* Pregnant women, nursing mothers or subjects who do not agree to assigned contraception in the study
* Participated in any other clinical trials within 30 days prior to the first administration
Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)

Review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as intraperitoneal chemotherapeutic agent.

Observation of primary outcome:

* Overall Survival
* Disease-free survival

Influencing factors that will be observe:

* Sex
* Blood loss
* Time of surgery
* Number of resection and anastomosis
* Peritoneal Index (PI score)
* Cytoreductibility (CCR score)

Eligibility Criteria:
Inclusion Criteria:

* Peritoneal mesothelioma

Exclusion Criteria:

* Non resectable disease
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3

This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.

This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) Estimate costs of ulcer prevention using these strategies. Patients from the Seattle VA (n=214) and Group Health Cooperative (n=213) will be randomly assigned to one of two study arms. They are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.

Eligibility Criteria:
Diabetics with foot ulcerations
DU and BOO in Women With and Without Symptoms of VD

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity or bladder outlet obstruction. However, the prevalence of detrusor underactivity and bladder outlet obstruction remained obscure. Thus, the aim of this study was to elucidate the prevalence of detrusor underactivity and bladder outlet obstruction in women with and without symptoms of voiding dysfunction.

Between February 2005 and December 2020, all women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of maximum flow rate, voided volume, post-void residual volume and detrusor pressure at maximum flow rate were excluded from this study. Detrusor underactivity was defined when the detrusor pressure at maximum flow rate was less than 20 cmH2O, the maximum flow rate was less than 15 mL/s, and the bladder voiding efficiency was less than 90 %. Bladder outlet obstruction was defined when the the detrusor pressure at maximum flow rate was not less than 40 cmH2O, and the maximum flow rate was less than 12 mL/s. Those women without detrusor interactivity or bladder outlet obstruction were allocated to the non-DU/BOO group.

STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression test were used for statistical analysis as appropriate. A p \< 0.05 was considered as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Women with lower urinary tract symptoms
* Complete urodynamic study

Exclusion Criteria:

* Advanced cystocele
* After surgery for cystocele repair
* Chronic infection
* Incomplete data
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Spain, as Part of Local Clinical Practice

The purpose of the study is to collect information on participant's blood sugar levels, body weight, how satisfied participant is with the treatment, and how participant takes his/her diabetes medicines. Participant will get Rybelsus® as prescribed by study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice
* Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
CARTO® 3 System and Real Time Intracardiac Ultrasound

This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.

Eligibility Criteria:
Inclusion Criteria:

* Drug refractory, recurrent symptomatic paroxysmal AF
* Age 18 years or older
* Patients able and willing to provide written informed consent to participate in the study and comply with study requirements

Exclusion Criteria:

* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous ablation for atrial fibrillation
* AF episodes that last longer than 30 days
* Uncontrolled heart failure, or NYHA Class III or IV heart failure
* Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
* Contraindication to anticoagulation
* Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
* Awaiting cardiac transplantation
* Heart disease for which corrective surgery is anticipated within 6 months
* Enrollment in other investigational drug or device study
* Subjects unwilling to comply with protocol or follow-up requirements
* Patients who are pregnant
YAZ, Oral Contraceptive Registration in China

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women between 18 and 45 requesting oral contraception.
* Smokers may not exceed 30 years of age.

Exclusion Criteria:

* The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study.
* Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
* Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea
* Any disease or condition that may worsen under hormonal treatment
* Other contraceptive methods such as sterilization or IUD/IUS
* Substantial overweight (BMI \> 30 kg/m2).
Outcomes of Hemiarthroplasty Versus Cephalo-medullary Fixation to Treat Unstable Intertrochanteric Femoral Fractures

Comparing functional outcomes of hemiarthroplasty (prosthetic joint) versus cephalo-medullary fixation ( proximal femoral intramedullary nail) in the treatment of unstable intertrochanteric femoral fractures (proximal femur fractures) in elderly people above 60 years old.

The intertrochanteric femoral fractures incidence rate has increased through the last years because of increasing life expectancy, leading to more morbidity and mortality rates . Unstable fracture pattern occurs due to age increase and bone quality decrease. Unstable intertrochanteric femoral fractures (ITFF) are considered about 40-45% of hip fractures in elderly people . Of note, 55% of these fractures had unstable patterns . The main objective of treatment is to restore the patients to their preoperative daily activities and medical conditions .

Therefore, the surgical treatment aims to return the patient to his pre-fracture level of activity to ensure that the patient moves as soon as possible to prevent complications due to immobility which can lead to death.

In an unstable fracture pattern which is characterized by decreased bone quality, it is of great importance to providing efficient and proper treatment . A lot of treatment modalities had been used in the treatment of this fracture pattern such as PFN, unipolar hemiarthroplasty, BHA, and dynamic hip screw (DHS) . On the other hand, it is difficult to perform stable fixation owing to osteoporotic bone quality.

The treatment aims to restore the patient's ambulation and decrease medical complications and technical failure. By using either BHA or PFN methods, patients can return to pre-injury levels decreasing complications induced by prolonged immobilization or implant failure .

The primary objective of the current study is to compare functional outcomes of unstable ITFF managed by PFN or BHA among cases with ages more than 60 years old. The second main objective is to compare intraoperative and postoperative in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 60 years old.
* Unstable intertrochanteric femoral fractures

Exclusion Criteria:

* patient with age less than 60 years old
* Hip osteoarthritis
* Pathological fractures
* Bilateral fractures
* Metabolic bone disease
* Multiple trauma
Analysis of a Virtual Reality Task in Patients With Duchenne Muscular Dystrophy

The task consists in reach as much bubbles as they can, the bubbles appear on the screen of the computer and should be reached in 10 seconds. To accomplish that, three different devices will be used: (1) Kinect for Windows Microsoft - which consists of a sensor that captures body movements (including upper limbs). And (2) the Leap Motion (LMCH, Leap Motion, Inc., San Francisco, CA, USA), and (3) Touch Screen. To describe motor impairments was used the Motor Function Measure Scale; Scale Vignos and Scale Egen Klassifikation;

To evaluate the performance of interaction devices was used a computer game proposed by the Department of Information Systems, University of São Paulo. Chosen due to its low cognitive demands, ease and adaptability for use in people with DMD. The program, offers a task designed to measure various neuropsychological aspects of planning, execution, spatial organization, which involves the operation of the intention to move to achieve a virtual object and the planning of this action.

Considering different interfaces, opted for three interfaces. Two of theme without physical contact, represented by (1) Kinect for Windows Microsoft - which consists of a sensor that captures body movements (including upper limbs). And (2) the Leap Motion (LMCH, Leap Motion, Inc., San Francisco, CA, USA) - virtual interface by means of a sensor, in which there is also no need to touch or physical contact , but its catchment area is focused only on hands and fingers. In addition, an interface that required physical contact -Touch Screen - a sensitive monitor to touch the computer screen itself. The use of interfaces with and without physical contact are interesting to identify the functionality of the devices.

Therefore, the game presented 126 bubbles arranged in rows and columns . The goal was that the participant could achieve (changing color) the largest number of bubbles during 10 seconds, thereby defining a range zone for the specified time.

After defining the scope zone, the therapist established a red target bubble, which was chosen in the center of bottom of range line. The participant should play this target bubble using one of the devices, Touch Screen, Kinect and Leap Motion. After touch of target bubble, the game had another red bubble in a random position, within range of area. After reaching the random bubble, the bubble target was displayed again, and so on. The game features red bubbles within the range area, and sometimes out of range, thus creating a higher degree of difficulty and to encourage participants to challenge their limits.

The Participants were divided into groups which performed the tasks with different interaction devices, more virtual feature (not touch the computer using Kinect or leap motion) or real (to touch the computer screen).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of DMD.

Exclusion Criteria:

* presence disorders in cognitive function that would prevent comprehension of the experimental instruction.
GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body Composition

Prader-Willi syndrome (PWS) is a genetic disorder associated with growth hormone (GH) deficiency, central hypotonia and hyperphagia that leads to life-threatening obesity. Treatment with GH in adult patients is not well stablished in guidelines of Health National System (HNS). The investigators has experience in the study of brain connectivity in these patients in relation to satiety. To date, there is no evidence about the effect of GH on central hypotonia (brain areas related with muscle tone maintenance). So, the main objective is to examine these anatomical areas before and one year after GH treatment.

Methodology: Structural and functional magnetic resonance imaging to 30 PWS patients before and after GH treatment and we will compare them to a control group.

Expected results: PWS group will show abnormal functional and structural connectivity in circuitry of muscle tone maintenance that will improve after GH treatment. These favorable changes and the absence of secondary effects will help to justify the use of this treatment and its inclusion in practical clinical guidelines of HNS for the management of this syndrome in the adulthood.


Eligibility Criteria:
Inclusion Criteria:

* PWS \>=18 years with growth hormone deficit
* Signed informed consent by the patients or their legal guardian

Exclusion Criteria:

* Severe obesity
* No controled diabetes mellitus
* No treated obstructive sleep apnea or severe obstructive sleep apnea
* Active cancer
* Active psychosis
Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.

To address the challenge of antimicrobial resistance (AMR) it is imperative that the current finite pool of antimicrobial agents is optimised, to maximise therapeutic success, limit the risk of drug toxicity, whilst minimising emergence of resistance.

Outside of the critical care setting it is not known how many patients are receiving optimal drug concentrations for the treatment of infection.

This study aims to assess whether antimicrobial targets are being achieved in these individuals and explore how clinical co-variates and outcomes may relate to this. Furthermore, it aims to identify priority groups and/or drugs where there are gaps in dose optimisation research and develop hypotheses which can be tested in observational studies.

Eligible participants will be enrolled and observed during their management of infection at Imperial College NHS Trust. After providing informed consent their clinical data will be collected from electronic healthcare records and they will provide samples that will undergo drug concentration analysis.

Eligibility Criteria:
Inclusion Criteria:

18 years of age or above.

* Under follow-up for management of infection at Imperial College NHS Trust
* Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently).
* Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee):
* Delirium which may be caused or exacerbated by having an infection.
* Suspected/confirmed central nervous system infection.
* Critical illness requiring sedation and/or intubation and ventilation which is caused by or exacerbated by having an infection.

Exclusion Criteria:

* Less than 18 years of age

  * Severe anaemia (Hb \< 70g/l)
  * Platelets \< 50x10\^9/l, INR \>1.5 or other known blood clotting impairment
  * Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study.
  * Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.
  * Patients with restricted liberty, prisoners or under legal protection.
Perinatal Interpersonal Psychotherapy Group for Distressed Women

This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored.

This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored. The third-trimester women were recruited as intervention and control group participants by a quasi-experimental design.

Eligibility Criteria:
Inclusion Criteria:

* women in the third trimester of pregnancy, at least 20 years old, able to read and write in Chinese, and "depressed, anxious, or wishing to improve family relationships."

Exclusion Criteria:

* women with schizophrenia, substance use, or suicide risk.
ED50 of Sufentanil for Intraoperative Analgesia

1. Sufentanil as an strong analgesic is used widespreadly during laparoscopic cholecystectomy.
2. Lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect.
3. The investigator are planning use the most classical method for determining the ED50 or half effective concentration of sufentanil facilitated with dexmedetomidine using sequential method, which is also called" up and down method" and" ladder method".

The concordance of the current research is that lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect through operation. However, the dosages of sufentanil used in various researches vary greatly of operations. Previous studies have shown that the amount of sufentanil required for intraoperative analgesia is smaller than that required while dexmedetomindine facilitated. Although the appropriate dosage of sufentanil required for operation can ensure the analgesic effect of operation, excessive dosage can cause severe choking during intubation, postoperative nausea and vomiting, hyperalgesia, and chronic postoperative pain. The investigator planning use the most classical method for determining the ED50 or half effective concentration of sufentainl combined with dexmedetomidine using sequential method, which is also called " up and down method" and " ladder method".

Eligibility Criteria:
Inclusion Criteria:

1. ASA I \~ II level;
2. BMI22-30kg/m2;
3. Those who intend to undergo laparoscopic cholecystectomy;
4. Age 18\~65 years.

Exclusion Criteria:

1. Has been allergic to the drugs used in this study;
2. Patients with a history of chronic use of alcohol, smoke or other sedative drugs;
3. Patients took opioids and other analgesics before surgery;
4. Emergency operation;
5. Stress, anxiety resulting in secretion of catecholamine;
6. Patients with neuropsychiatric disorders, coma, depression, cognitive impairment and Alzheimer's disease;
7. Patients with epilepsy, autonomic nervous dysfunction and other diseases with abnormal EEG results;
8. SBP\< 85 mmHg or HR\< 45次/min;
9. Has implanted pacemaker;
10. Patients were unwilling or disable to finish whole study;
11. Patients with acute upper respiratory infections, liver or kidney failure and severe cardiopulmonary dysfunction.
Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program.

Oocyte donation is an assisted reproduction technique well established. In patients with ovarian function, it is necessary to synchronize the cycle of the egg donor with the recipient, usually through endometrial preparation of the recipient by artificial cycle, by administering a GnRH agonist on day 21 of cycle and then administered increasing doses of estrogen therapy to achieve adequate endometrial thickness.

The necessity of synchronization between donors and recipient, has made possible not routinely the natural cycle for oocyte donation.

The investigators have recently introduced oocyte vitrification and it allows us to plan the egg donation in a different way. Now the investigators can previously cryopreserved donor oocytes and at the time that the investigators have a compatible receiver, then, plan the donation In this study it will be possible compare the results of oocyte donation cycles in terms of pregnancy rate, implantation and liveborn, depending on whether the recipient has made an artificial cycle of preparation endometrial or a natural cycle.

Eligibility Criteria:
Inclusion Criteria:

* infertile females with preserved gonadal function
* ages 18 - 44 years old included
* first oocyte donation cycle

Exclusion Criteria:

* BMI: \> 28
* recurrent miscarriages (3 or more)
* recurrent of implantation failure
* severe male factor
* important miomas
* \> 44 years old
* Problems with the drugs used in the study