cyrilzakka/clinical-trials huggingface dataset:
OPIE in the Thin Interventricular Septum

This is a follow up investigation to our previous study entitled "On-pump intraoperative echocardiography (OPIE)" (clinicaltrials.gov NCT03094325) whereby we determined that left ventricular septal thickness as measured by the OPIE technique correlates highly with traditional methods of transthoracic and transesophageal echocardiography during septal myectomy for hypertrophic cardiomyopathy. OPIE may be especially useful in patients with a thin ventricular septal thickness as adequate treatment may rely on mere millimeters of myocardial resection. We therefore propose a study in which OPIE is compared to transthoracic and transesophageal echocardiography in patients with a thin interventricular septum. Subjects will receive the same perioperative care regardless of their involvement in the study. Patients who enroll in the study will undergo an additional intraoperative echocardiographic measurement that adds less than five minutes to total operative time.


Eligibility Criteria:
Inclusion Criteria:

* All hypertrophic cardiomyopathy patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy with a preoperative transthoracic echocardiograph suggesting an interventricular septal width of less than 2.0 cm.

Exclusion Criteria:

* Those hypertrophic cardiomyopathy patients who are scheduled to receive a septal myectomy who are less than 18 years old or whose preoperative transthoracic echocardiograph suggests an interventricular septal width of greater than 2.0 cm.
Novel Combined Function Test for Patients on Peritoneal Dialysis

Peritoneal membrane function tests such as the traditional peritoneal equilibrium test (PET) aid in the assessment of various peritoneal membrane functions, and are widely used in clinical practice to guide dialysis prescription, and also to monitor the integrity of the peritoneal membrane over time. Traditional tests do however have several shortcomings such as being time consuming, complex, and having a low reliability. Also, present functional tests often provide limited information such as small solute transfer rates, which means that other functional changes go unnoticed.

The present study investigates the reliability of a novel short (60 min) test, with the potential of replacing complex and time-consuming conventional tests. The novel test provides a comprehensive assessment on both water- and solute transfer across the peritoneal membrane, including the osmotic conductance to glucose (OCG), small solute diffusive conductance (in terms of the diffusive surface to diffusion length ratio, A0/Δx), and also macromolecular transport and apparent fluid absorption. In contrast to conventional tests, multiple fill volumes may be used and results are also applicable to all glucose strengths used in conventional peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Peritoneal dialysis treatment duration of at least 1 month
* No recent peritonitis (a minimum of 1 month since the last peritonitis)

Exclusion Criteria:

* Pregnancy
* Participant unable to provide informed consent
* Peritonitis
* Other acute infections
Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP


Eligibility Criteria:
Inclusion criteria (MRA011JP patients)

* Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
* the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
* Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
* Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period

Exclusion criteria

* Patients who were not enrolled by 3 months after completion of the previous study
* Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study
Apnea and Insomnia Relief Study

The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).

This study is a randomized controlled trial of a behavioral sleep treatment to improve functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home). The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and CPAP adherence. Participants will also provide treatment feedback to aid in assessment of treatment feasibility and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study and recommended for PAP therapy
* Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder
* Meet DSM-5 Criteria for Insomnia Disorder
* Willing to attend all treatment and assessment appointments
* English literacy and cognition sufficient to participate in treatment and assessment

Exclusion Criteria:

* Psychosis or manic episode in last 5 years
* Moderate or severe substance use disorder in past 6 months
* Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month or plans to discontinue this treatment during the trial
* Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month or plans to discontinue this treatment during the trial
* Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety
* Untreated sleep disorders that may interfere with successful treatment (up to discretion of Principal Investigator)
* Having travel of personal plans that would disrupt regular treatment engagement (up to discretion of Principal Investigator)
* Working night shifts or rotating shifts that include night shifts
* Lack of stable housing
* Pregnancy
Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts

Specific stabilization training targeting the deep trunk muscles has shown good effect in the rehabilitation of Low Back Pain (LBP) in young female TeamGym (TG) gymnasts. However, if this training can prevent LBP in this young population remains to be investigated. The aim of the present study was to investigate if a specific lumbar stabilization program can reduce and prevent LBP in young female TG gymnasts.

Objectives: To study if a progressive specific lumbar stabilization program can reduce and prevent low back pain (LBP) in young female TeamGym (TG) gymnasts aged 10-16 years.

Design A cluster randomized controlled intervention study

Participants: All available competitive youth female TG teams including gymnasts aged 10-16 years, in the area of Stockholm, were invited to participate in the present study. A team consists of approximately 16 gymnasts. Fourteen out of 17 teams and a total of 258 gymnasts accepted to participate. Gymnasts and parents were informed about the study and written consent was collected. A cluster randomization process was undertaken as follows: the gymnasts in each team answered questions at inclusion and the teams were matched with respect to age, level of competition, amount of training sessions per week and reports of LBP. LBP in this study was defined as; "pain between the 12th rib and the gluteal fold". Thereafter a cluster randomization took place. This means that all gymnasts in one team were either in the control or in the intervention group. There were no differences with respect to demographic and training data and reports of LBP between the two groups at randomization. Ninety gymnasts did not report LBP at inclusion or during baseline and were included in a subgroup analysis on the preventive effect of the exercise program.

Methods Every week the gymnasts were visited by a registered physical therapist (RPT). The RPT answered questions from the gymnasts concerning injuries and collected a weekly-based questionnaire. The gymnasts in the intervention group were instructed to perform an eight-week progressive specific lumbar stabilization program, implemented in the warm-up at every training session. The gymnasts answered a weekly based questionnaire regarding training and LBP during the intervention period, and thereafter a questionnaire at 3-, 6- and 12 months follow-up. The gymnasts and the coaches were also instructed to continue with the lumbar stabilization program after the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* female TeamGym teams, aged 10-16 years, in the Stockholm area
* competing at national or international level

Exclusion Criteria:

* male TeamGym gymnasts
* female TeamGym teams on a regional competitive level
Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety

The purpose of this trial is to evaluate the efficiency and safety of Chidamide in advanced cephalic and cervical adenoid cystic carcinoma. Chidamide is given to patients with advanced cephalic and cervical adenoid cystic carcinoma with the dosage of 30mg,twice a week, then overall survival, event-free survival are accessed for efficiency, and laboratory tests about the function of vital organs are accessed for safety.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of advanced cephalic and cervical adenocystic carcinoma with pathological and imaging evidences, with local relapse or metastasis or refractory towards treatment.
2. Age 18-75, male or female, expected survival≥ 3 months.
3. ECOG 0-2.
4. With at least one evaluable disease focus.
5. Organ functions should fit the following:

Liver: Total bilirubin ≤ 1.5 times of the normal maximum, ALT and AST≤ 2.5 times of the normal maximum. (ALT/AST≤ 5 times of the normal maximum for patients with infiltrative liver disease) Kidney: Serum creatinine ˂ 1.5 folds of the normal maximum; creatinine clearance rate ≥50ml/min (calculated by Cockroft-Gault10 formula)

Exclusion Criteria:

1. History of HDACI treatment.
2. Women during pregnancy or lactation.
3. Patients with a second primary tumor ( this does not include non-melanoma skin cancer received systemic treatment, cured cervical carcinoma in situ of the uterus, or other tumors that have been cured with disease free survival˃ 5 years)
4. Patients with central nervous system defects or mental disorders.
5. Other diseases or contraindications: History of heart disease within 6 months prior to inclusion, including NYHA III-IV heart failure after treatment, coronary heart disease, angina pectoris, myocardial infarction, degree II or III atrioventricular block, severe arrhythmias that need medical treatment, uncontrolled hypertension; liver cirrhosis (Child-Pugh B or C); active infection that has not been controlled, and other conditions that may make the patient unable to complete the trial.
The Role of Food Sensitivity in Psoriasis

Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms. The purpose of this study is to determine whether psoriasis patients are more likely to have food sensitivities than those patients without psoriasis. We will also determine if eliminating certain foods from the diet results in a change in psoriasis symptoms.

Purpose: To determine the role of food sensitivity in psoriasis and assess the clinical response of an individualized elimination diet on psoriasis.

Design: Up to 50 volunteers with psoriasis and 20 age- and sex-matched controls will be recruited for a 12-week prospective correlational study.

Methods: Venous blood samples for the detection of antibodies against food antigens will be collected and individualized elimination diets will be designed based on the most reactive food antigens.

Assessments: Clinical assessments of objective and subjective parameters will be measured using Psoriasis Area and Severity Index (PASI), Static Physicians Global Assessment (sPGA), Dermatology Life Quality Index (DLQI), and Itch Numeric Rating Scale (Itch NRS).

Objectives: The primary objectives are to determine whether psoriasis patients are more likely to have food sensitivities and assess the clinical response of a 12-week elimination diet on psoriasis.

Eligibility Criteria:
Inclusion criteria:

* Male or female subjects, 12 years of age or older.
* Good general health.
* Willingness and ability to follow the protocol.
* Signed Informed Consent Form, written and witnessed.
* Psoriatic group only: Chronic plaque psoriasis (patients must have diagnosis for at least 6 months) or guttate psoriasis involving 2 % or greater total body surface area or 2 plaques, each measuring \> 8 cm2.
* Psoriatic group only: Psoriasis is untreated (as defined in Exclusion criteria 4) or subject has been on a stable topical or systemic treatment with no dose alteration or regimen alteration for \>12 months.

Exclusion criteria:

* History of drug-induced psoriasis or pustular psoriasis.
* Moderate or severe psoriasis warranting systemic immunosuppression or inpatient admission.
* Pregnant, lactating, history of diabetes mellitus, thyroid disease or inflammatory bowel disease.
* Psoriatic group only: Use of biologic treatment for psoriasis within 3 months of baseline, use of systemic immunosuppressive treatment for psoriasis within 4 weeks of baseline, or use of topical treatment for psoriasis within 2 weeks.
Efficacy and Safety of Telmisartan and Losartan in Primary Hypertension

Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China


Eligibility Criteria:
Inclusion Criteria:

- Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and \< 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) \< 180 mmHg

Exclusion Criteria:

- Not specified
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Stable fiber therapy
* Normal colonoscopy/sigmoidoscopy
* Able to refrain from use of medications known to treat or associated with constipation symptoms
* Experiences abdominal discomfort/pain associated with bowel movements
* Reports decreased bowel movement frequency and/or other symptoms associated with constipation

Exclusion Criteria:

* Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS
* Open gastrointestinal or abdominal surgery prior to IBS onset
* Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
* Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
* If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
Scopolamine Challenge Study

It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive impairments in healthy adults subjects.

Proof of mechanism

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive.
* Body Mass index (BMI) of between 17.5 to 30.5 kg/m2 inclusive; and a total body weight greater than or equal to 50 kg (110 lbs).

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program

More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis (stage 0-III)
* Body mass index of 25mg/k2 or greater
* Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
* Able and willing to participate in nutrition counseling at Maroone Cancer Center
* Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing
* Participants must have the ability to understand and the willingness to sign a written informed consent document
* Performance status 0 or 1 as per ECOG scale \[see Appendix IV\]

Exclusion Criteria:

* Body mass index below 25kg/m2
* No prior history of breast cancer
* History of metastatic disease
* Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
* Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center
* Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.
Timing of Suture Removal to Reduce Scarring in Skin Surgery

This is a single centre prospective randomized assessor blinded parallel group feasibility study that will be undertaken in the Royal Devon and Exeter Dermatology department.

The investigators will be looking at whether timing of percutaneous suture removal after skin surgery impacts on the incidence of suture marks and overall scar cosmesis.

Stitch marks (also known as suture marks or track marks) are permanent marks left in the skin where the stitch has caused local tissue damage and scarring. The risk of these marks is in part thought to be related to the length of time that the stitches are left in place before removal. Stitches are normally left in place for longer on sites where the skin is under greater tension such as the chest or back because there is a concern that the wound may be more likely to open up on these sites. On the chest or back, stitches may be left in place for up to 14 days even though the chest or back is a common site for stitch marks to form.

The investigators are conducting a single centre prospective randomized assessor blinded parallel group feasibility study to estimate a sample size required for a properly powered RCT, and also to provide some preliminary data on the incidence of wound complications and overall scar cosmesis in each group.

All patients attending the dermatology department for wide local excision as part of their skin cancer treatment and primary closure of the subsequent wound will be considered for entry into the trial. Clinicians will identify potential participants during routine practice at their clinic visit. Patients who fulfil the entry criteria will be invited at that appointment to take part.

On the date of participants skin surgery, they will be consented and randomized to either 'suture removal at 7 days' or 'suture removal at 10 days'. Participants will then be booked for a 3 month follow up where the scar site will be evaluated from a patient and clinician perspective to assess suture marks and overall cosmesis.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years old or above who had capacity to consent to surgery who were willing to attend follow-up appointments within the department

  * Patients undergoing wide local excision as part of their skin cancer treatment pathway
  * Lesions excised from the anterior chest or back
  * Post-operative wound \>/= 10mm width
  * Wound could be closed with primary intention healing

Exclusion Criteria:

* Inability to provide valid informed consent and/or unwilling to attend for follow-up

  * Wounds where the edges could not be closely adhered with dermal sutures alone.
  * Wounds requiring a flap or graft for closure.
  * Patients requiring further treatment following original excision eg. Further WLE, radiotherapy etc.
Investigation of Pelvic Floor Muscle Strength in Low Back Pain

To evaluate the effect of pelvic floor muscle strength on women with non-specific low back pain


Eligibility Criteria:
Inclusion Criteria:

* being a woman
* 18-50 years old
* BMI≤30

For The NSLBP Group:

* diagnosed with non-specific low back pain by a specialist physician,
* have low back pain for at least 3 months,
* have no pain radiating to the leg,
* have low back pain 3 or higher on the visual analog scale (VAS, 0-10 scale)

Exclusion Criteria:

* have a somatic or psychiatric disorder,
* have signs and symptoms associated with other conditions such as nerve root compression (at least 2 of these symptoms: weakness, reflex changes or loss of sensation associated with the same spinal nerve),
* have had previous spinal surgery or are scheduled for surgery,
* Pregnant
* have neurological and pelvic inflammatory diseases