cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy


Eligibility Criteria:
Inclusion criteria:

* Male and female patients (\> 18 years) with prior surgery of micro- or macroadenoma of the pituitary.
* At least 6 months chronic treatment with 30mg octreotide (long acting release).
* Partial responsiveness, which is defined as follows: at any one point within the 6 months monotherapy with 30mg/month octreotide (long acting release) the patient must have experienced a decrease in GH and IGF-1 of at least 25% as compared to pre-monotherapy values (= baseline). Note: For efficacy analysis GH- and IGF-1-values measured in the central laboratory at visit 1 (=study baseline) will be used.
* Lack of suppression of GH nadir to \< 1.0 µg/L, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD (adjusted for age and gender; Brabant 2003) must be proven within 4 weeks prior to visit 1. However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient.
* Patient's written informed consent.

Exclusion criteria:

* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass.
* Radiotherapy planned or radiotherapy for acromegaly within the last 2 years.
* Symptomatic cholelithiasis that is clinically relevant.
* Receiving treatment with dopamine agonists within the last 6 months or prior treatment with GH-receptor-antagonists.
* Patients with renal insufficiency, Raynaud-Syndrome or gastrointestinal ulcer/ bleeding cannot be included in the study or psychose in anamnesis.

Other protocol-defined inclusion/exclusion criteria may apply
Post Abortion IUD & Recurrent Abortion 2001-2004

It has been shown that the immediate insertion of intrauterine devices (IUDs) post-abortion prevents repeat abortions. The researchers hypothesize that providing free IUDs post-abortion will be associated with a lower rate of repeat abortion in a Canadian population. Further, the researchers hypothesize that providing free IUDs post-abortion will be associated with decreased costs for the health care system.

The researchers intend to demonstrate whether there are statistically significant differences in the rates of repeat abortions between three groups: 1. women choosing to have an intrauterine device (IUD) inserted immediately post-abortion, 2. those choosing to begin oral contraceptives immediately post-abortion, and 3. all other choices for post abortion contraception including those stating an intention to obtain contraceptives at a later time or from an alternate location or to use no contraception. This data will then be used to conduct a cost-effectiveness analysis of health system provision for cost-free IUDs post-abortion.

The researchers will conduct a retrospective observational cohort study by chart review. The researchers propose to review the charts of 600 women undergoing abortions between January 1, 2001 and December 31, 2004 at Kelowna General Hospital's Women's Services Clinic. The researchers will record the following data from each chart: age, parity, gestational age, date of index therapeutic abortion (TA), dates of subsequent TAs, contraception used at the time of the index conception, contraceptive method chosen post-abortion, and outcome of follow-up at two weeks, such as expulsion of IUD. The researchers will also record the recurrent pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* Female resident of Interior Health region seeking an abortion between January 1, 2001 and December 31, 2004

Exclusion Criteria:

* Women undergoing abortions for fetal genetic abnormalities
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)

The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049.

The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.

Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study.
* Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements.

Exclusion Criteria:

- Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.
Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is responsible for an increase in quality of life related to nasal obstruction when compared to no intervention in rhinoseptoplasty inferior turbinate?

* Population: patients eligible for functional rhinoseptoplasty and / or aesthetic
* Intervention: surgery, turbinectomy of inferior turbinates
* Comparison: the absence of intervention in inferior turbinates
* Primary endpoint: Quality of life related to nasal obstruction


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients to rhinoseptoplasty
* Patients who agreed to participate

Exclusion Criteria:

* Presence of symptoms of nasal obstruction in the absence of septal deviation, poor support of the nasal tip or clamping of the nasal valve;
* Presence of hypertrophic and obstructive inferior turbinates;
* Presence of sinonasal tumors;
* Patients undergoing treatment of other concomitant rhinoplasty entities such as inflammatory sinus pathology, adenoid hypertrophy, septal perforation, otoplasty and blepharoplasty.
Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

The study will assess the safety, tolerability, drug label and effect in subjects with and without insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects with insulin resistance
* Subjects with controlled hypertension and hyperlipidemia

Exclusion Criteria:

* Smokers
* History of drug or alcohol use
* Autonomic dysfunction
* Significant illness or cardiovascular disease
* Immunodeficiency disease

Other protocol-defined inclusion/exclusion criteria may apply
Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents

This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.

Numerous advancements in mental health treatment have been made over the past decade. Unfortunately, these advancements have focused on adults and have not been fully extended to children and adolescents. With limited pediatric information on the pharmacokinetics and pharmacodynamics for drugs used to treat mental health problems, psychiatrists are prescribing drugs for children using data extrapolated from adults, which may lead to potentially life-threatening results. Olanzapine is widely prescribed to treat both children and adults. This study will determine the safety and effectiveness of olanzapine in children and adolescents with mental health disorders. The study will also compare the effects of gender, development, body composition, and metabolic genotype and phenotype on how olanzapine works.

All participants will receive olanzapine for up to 8 weeks. Blood collection will occur at each weekly study visit. On Visit 1, participants will receive their first dose of olanzapine and repeated blood collection will occur every hour for 24 hours. Blood collection will be used to determine the time it takes for olanzapine to be absorbed into the body, its duration of action, the extent of its distribution in the body, the manner in which it is excreted from the body, and its effects on organs of the body.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder with mania, mixed mania, or psychosis not otherwise specified
* Meet certain laboratory result requirements
* Have taken either lithium or valproate for 4 weeks or longer with no or only partial response
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

* History of other serious unstable illness requiring medication
* Diabetes mellitus
* Abnormal physical examination and electrocardiogram (EKG) results
* At risk for suicide or homicide (based on an assessment of suicidal history, intent or plan, mental state, mood, and substance use)
* IQ less than 65
* History of organic brain disease or seizure disorder
* Recent exposure to an infectious disease, such as tuberculosis (TB) or meningitis
* Current use of drugs that may interfere with the metabolism of olanzapine and unwilling to discontinue use during the study
* Body mass index (BMI) less than the 5th OR greater than the 95th percentile for age and gender
* History of smoking within 1 year prior to study entry
* Pregnancy or breastfeeding
Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. The investigators' study group has developed modified versions of such supplements that theoretically will supplement infants diets better and with lower cost. As a preparation for larger efficacy trials, the investigators now aim to test the acceptability of these supplements among Malawian infants and their guardians. The trial hypothesis is that the infants will consume on average at least 50% of an offered dose that consists of LNS mixed with maize porridge.

In the first phase, 18 infants meeting set criteria are randomised into receiving three test meals with novel LNS preparations over a three-day period. The meals will consists of the following, each given on one day and in a random order: 1) 7.5 g of LNS-10gM mixed in 30 g maize-soy porridge, 2) 15 g of LNS-20gM mixed in 30 g maize-soy porridge, 3) 15 g of LNS-20gNoM mixed in 30 g maize-soy porridge. As a run in procedure, each participant will undergo a test feeding session with one of the the test foods on the day before the actual test-feeding period. As a positive control, each participant will undergo test feeding session with standard Nutributter (NB) on the day after the actual test-feeding period.

In the second phase a set of 48 infants are randomised into 3 groups receiving the following food supplements for a period of 2 weeks: 1) 10 g/day of milk-containing, very concentrated LNS (LNS-10gM), 2) 20 g/day of milk-containing, concentrated LNS (LNS-20gM), 3) 20 g/day of milk-free, concentrated LNS (LNS-20 g NoM)

Outcomes measures in the first phase will be assessed through safety reports and quantities of test food consumed by the child and a hedonic scale of acceptability by the mothers of the children. The second phase will be assessed with qualitative outcomes, from data obtained from focus group discussions with the guardians of the infants consuming the test foods.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from at least one guardian
* Age 7.50 months to 11.49 months
* Currently breastfeeding
* Consuming complementary feeds at least 30 days prior to enrollment
* Availability during the period of the study

Exclusion Criteria:

* Weight for length Z score (WFH) ≤ -2.0 using WHO growth reference standards or the -presence of oedema
* Severe systemic illness warranting hospital referral
* History of allergy towards peanut
* History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
* Congenital malformation such as cleft palate which may interfere with food intake
* Concurrent participation in any other clinical trial
Comparative Effectiveness of Intubating Devices in the Morbidly Obese

This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used.

The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.

Hypothesis: the use of a video laryngoscope will improve the glottic view compared to direct laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to achieve successful tracheal intubation in patients undergoing bariatric surgery. (Weight loss surgery). The three types of video laryngoscopy devices include; the Verethon GlideScope, LMA McGrath and Karl-Storz Video-Mac.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented body mass index (BMI) of \>35.
* Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
* Willingness and ability to sign an informed consent document
* 18 - 80 years of age
* American Society of Anesthesiologists (ASA) Class II- III adults of either sex.

Exclusion Criteria:

* Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
* Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery
* Emergency surgeries
* Pregnancy
* The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia.
* Any other conditions or use of any medication which may interfere with the conduct of the study.
International Validation of Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms

1. Deploy wearable COVID sensor to collect high resolution physiological data (temperature, cardiac, respiratory and physical activity) from COVID positive patients.
2. Use collected data to train algorithm for assessing the risk of individuals presenting with symptoms suggestive of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18-95 years old
* Currently experiencing any COVID-like signs and symptoms such as fever, cough, shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusion or inability to arouse, bluish lips or face.
* Individuals who are not experiencing any COVID like signs and symptoms (will be asked to be healthy control)
* Able and willing to give written consent and comply with study procedures.

Exclusion Criteria:

* Inability to understand instructions and follow a three step command.
* The subject is pregnant, nursing or planning a pregnancy.
* Inability to provide written consent.
Health Effects of Mentoring

The purpose of this study is to determine whether mentoring is associated with beneficial cardiovascular health effects in both mentors and mentees.

Participants are randomly assigned to either being a mentor or a wait list control. These participants are drawn from a population of undergraduate students. Participants are also randomly assigned to either being a mentee or a wait list control. These participants are drawn from a population of Chicago Public School children. In total, there will be 30 mentors, 30 control mentors, 30 mentees, and 30 control mentees. Participants will come for a laboratory visit in which cardiovascular health measures will be taken (details below). Visits will occur once at baseline (before the intervention starts), and once post-intervention. The protocol will be the same at the two study visits. Participants in the intervention group will engage in one-on-one mentoring sessions (between mentors and mentees) once a week after school for the school year

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate student for mentors.
* Chicago Public School student for mentees.

Exclusion Criteria:

* Younger than 9 or older than 14 for mentee conditions.
A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.

Study I1F-MC-RHBH is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study examining the effect of 2 dose regimens of ixekizumab versus placebo in participants with moderate-to-severe plaque psoriasis (Ps) during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, 48-week maintenance dosing period. During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse or rebound following treatment withdrawal, and response to retreatment following relapse.

Eligibility Criteria:
Inclusion Criteria:

* Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline.
* Have ≥10% BSA involvement at screening and baseline.
* Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline.
* Are candidates for phototherapy and/or systemic therapy.

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.
* Drug-induced psoriasis.
* Ongoing use of prohibited treatments.
* Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the IL-17 receptor.
* Have concurrent or recent use of any biologic agent within washout periods or \<5 half-lives prior to baseline, whichever is longer.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Duodenal Switch With a Standard Versus Long Alimentary Limb

The aim of this study was to determine if Biliopancreatic Diversion with Duodenal Switch (BPD-DS) with a longer strict alimentary limb at the expense of a shorter biliopancreatic limb will offer significant weight lost, but with lesser gastrointestinal complaints, protein deficiency, vitamin and trace element deficit compared to standard BPD-DS.

This two-group, randomized, single-blind pilot study is conducted in a university-affiliated tertiary care center. The study protocol was approved by our ethic committee. Enrollment and randomization of the patients occurred between May 20163 and June 2015. Patients are undergoing follow-up evaluation. Patients were initially referred to our center for a bariatric surgery evaluation. Eligible patients were 18 years of age or older and met the criteria for a laparoscopic biliopancreatic diversion. Patients were excluded if they had a BMI ≥ 50 mg/m², a pacemaker, cirrhosis or if they were planing pregnancy in the next 2 years. Each patient was required to provide written informed consent. Patients were randomly assigned in a 1:1 ratio to undergo a standard biliopancreatic diversion (control group) or a modified biliopancreatic diversion with a longer strict alimentary limb (study group). A sealed envelope with the assignation was given to the surgeon in the operation room just before the procedure. Patients are followed every 6 months after surgery, up to 24-months for clinical evaluation, resolution of comorbidities, evaluation of side-effects, quality of life, bioimpedance testing and bloodwork.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for a biliopancreatic diversion, BMI above 35 with comorbidities or above 40 without comorbidities

Exclusion Criteria:

* BMI ≥ 50 mg/m², pacemaker, cirrhosis or planning pregnancy in the next 2 years, hypoalbuminemia, irritable bowel syndrome.
Clinical Values of Mature Fistulas in Hemodialysis

The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and fistula-first is the general recommendation for all HD patients. But in clinical practice in China, quite a few patients start HD before AVF maturation due to various situations. Whether HD initiation with mature AVF will influence the patency and complications is controversial. This study is aim to compare the AVF patency in incident HD patients with mature or immature AVF on HD initiation, and to compare other clinical outcomes, including abandonment without use, infection, and other AVF complications occurrence.


Eligibility Criteria:
Inclusion Criteria:

* underwent initial upper-extremity AVF creation for incident HD at Zhongshan Hospital, Fudan University

Exclusion Criteria:

* with malignancies
* not followed-up at Zhongshan Hospital, Fudan University
Effects of Neural Slump Mobilization in Addition to Conventional Physical Therapy in Low Back Pain

Low back pain is amongst the most prevalent musculoskeletal conditions worldwide.This condition has a significant impact on the person's quality of life by effecting their various activities of daily living. As of 2017 it remains the leading cause of years lived with disability.Various management strategies are used for the treatment of low back pain. In the recent years neurodynamic techniques are being used for the treatment of low back pain. Escpecially, patients of low back pain who have neural mechanosensitivity may benefit from neural mobilization techniques. Slump stretching is a neurodynamic technqiue which is used to improve the mobility of dural tissue.Different studies have shown postive results of slump stretching in patients of low back pain. However no such study has investigated the role of slump stretching in improving range of motiion in low back pain patients.So this study aims to investigate the the effect of slump stretching in low back pain patients specially on low back Low back pain is amongst the most prevalent musculoskeletal conditions worldwide.This condition has a significant impact on the person's quality of life by effecting their various activities of daily living. As of 2017 it remains the leading cause of years lived with disability.Various management strategies are used for the treatment of low back pain. In the recent years neurodynamic techniques are being used for the treatment of low back pain. Escpecially, patients of low back pain who have neural mechanosensitivity may benefit from neural mobilization techniques. Slump stretching is a neurodynamic technqiue which is used to improve the mobility of dural tissue.Different studies have shown postive results of slump stretching in patients of low back pain. However no such study has investigated the role of slump stretching in improving range of motiion in low back pain patients.So this study aims to investigate the the effect of slump stretching in low back pain patients specially on low back


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-44 years
* Both males and females
* Persons with low back pain with a positive slump test
* Patients with a NPRS intensity of at least 5

Exclusion Criteria:

* Patients with signs or symptoms of nerve root involvement
* Pregnant females, patients with history of spinal surgery, patients of spondylolistheis, spinal stenosis and disc herniation.
* Patients with serious spinal conditions infection, tumors, osteoporosis, spinal fracture