cyrilzakka/clinical-trials huggingface dataset:
Relapse Predicting Model for First Episode Depression

Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.

Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.

This study includes two steps. Step 1: Big data analysis based on the clinical features and immunochemical figures of 30000 patients with first episode MDD will be conducted to construct a relapse predict model.

Step 2: 300 patients with first episode MDD will be recruited in this step. Physicians prefer to give corresponding treatment recommendation based on the predictive factors to verify this relapse model.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years old;
* Han Chinese;
* Outpatient and inpatient patients;
* Patients met Diagnostic and Statistical Manual of Mental Disorders(DSM-IV-TR) criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
* Hamilton Depression Scale(HAM-D) total score≥17, HAM-D item 1 (depressed mood) score≥2, and Young Mania Rating Scale(YMRS) total score≤10 at baseline;
* Written informed consent was given;
* Junior high school education and above, with enough audio-visual ability to accomplish the visits;
* Normally resident in one country and had a residential address, able to follow-up.

Exclusion Criteria:

* Bipolar disorder rapid cycling or mixed episode;
* Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
* Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
* Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
* Female patients who were pregnant, planning to be pregnant or breast feeding;
* Severe medical or neurological problems.
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* post-menopausal women with osteoporosis;
* \<=80 years of age;
* naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for \>1 year.

Exclusion Criteria:

* metabolic bone disease other than post-menopausal osteoporosis;
* treatment with other drugs affecting bone metabolism within last 6 months;
* previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).
Evaluation of Adherence and Engagement in a Cognitive Training Program for Older Adults

There is evidence that computerized cognitive training can improve cognition in healthy older adults and in people at risk of developing dementia, although an effective model to implement the training in the daily life of people and to ensure engagement is missing. This project studies the adherence, engagement and progress on computerized cognitive training exercises that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte and Brasilia) received licenses to perform the exercises on line and were followed by a team of psychologists. We will evaluate adherence, engagement and progress on the computerized cognitive training exercises of those subjects.


Eligibility Criteria:
Inclusion Criteria:

* To be an associate of ASASTEL, or the spouse of an associate,
* To have access to the internet at home and proficiency on accessing and navigating the internet,
* Availability to be evaluated and followed by the professional team.

Exclusion Criteria:

* Any medical condition that precludes performing the computerized training exercises,
* Score below 27 points in the Mini Mental State Examination (MEEM),
* Moderated or advanced dementia.
OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)

The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.

This is a dose-finding study to select a safe and efficacious dose of OPT-80. Patients will be evaluated for safety and efficacy and pharmacokinetic parameters will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CDAD

Exclusion Criteria:

* Patients with severe CDAD
FRESH-DOSE: Families Responsibility Education Support Health-Dual Options for Sustained Effectiveness

The objective of the study is to evaluate whether a less intensive intervention, Guided Self-Help Family Based Treatment (gshFBT), is non-inferior to the more intensive Family Based Treatment (FBT) for childhood obesity on child weight loss over 18-months. Cost-effectiveness of both treatments will also be compared.

The primary aim of this project is to determine whether gshFBT is non-inferior to FBT for childhood obesity on child weight loss. Four assessments will be conducted; baseline (month 0), month 6 (post-treatment), and at month 12 and month 18. Assessments will include the following for child and parent: anthropometry, physical activity, nutrition, and cost-effectiveness. Cost-effectiveness will be calculated from a societal perspective and a third party payor perspective. This program of research has the potential to advance the standard of practice for children who are overweight or obese by providing a less intensive but more cost-effective intervention.

Eligibility Criteria:
1. An overweight child age 7-12, whose BMI is ≥ 85th percentile but does not meet criteria for severe obesity (i.e., BMI ≥120% of the 95th percentile or an absolute BMI ≥ 35 kg/m2 , whichever is lower for age and gender)
2. The parent willing to participate can read English at a minimum of a 5th grade level
3. Parent and Child willing to commit to attending all treatment and assessment sessions and be randomized to either treatment arm
4. Child or parent is free from psychiatric illness than may affect participation;
5. Child does not have any medical conditions that impact weight or may affect participation in physical activity or treatment
6. Child is not taking medications that may impact their weight (unless medication dosage is stable and not for the purpose of impacting weight and appetite)
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Ability to follow study instructions and complete study assessment tools

Exclusion Criteria:

* History of cardiovascular disorders
* Any type of implanted pacemaker/defibrillator
* Hypertension
* Diabetes Mellitus
* Local dermatological disease
* Local skin irritation/lesions
* Any neurological disorder
* Any psychiatric disease and/or psychiatric medications
Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift

The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery, and also studied the influence of some surgical procedures on the prognosis.

Pelvic organ prolapse is defined as a downward descent of the pelvic organs that results in the protrusion of vagina, uterus, or both. The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery. The investigators also studied the influence of some surgical procedures on the prognosis. In this study，The investigators divided the patients randomly into three groups :the group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)；the group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh；the group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.The investigators did POP-Q measurements and questionnaire preoperatively and postoperatively and recorded volume of bleeding，day of postoperative indwelling catheter and the mesh complications。

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage III \~ IV degree of anterior and posterior vaginal wall prolapse and uterine prolapse (total pelvic floor prolapse) by the Pelvic Organ Prolapse Quantification System (POP-Q) were included

Exclusion Criteria:

* Simple anterior or posterior wall prolapse, simple uterine prolapse, combined with stress urinary incontinence, overactive bladder (OAB), pelvic floor repair surgery history and recurrent patients
* Local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position)
* Vaginal bleeding;coagulation disorders
* Infection,or uncontrolled hypertension and diabetes mellitus
* Pelvic cancer and radiation to the pelvic area in the previous 6 months.
* Also women of reproductive age, and planning of pregnancy were also excluded for mesh usage.
Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

This prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (PROMs) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure.

Given the substantially lower implant removal rate in combination with a high union rate with the dual mini-fragment technique, we do not believe there is clinical equipoise required for a randomized clinical trial.

This study is a multi-centre, prospective cohort study (11 sites confirmed to date) of all operatively treated clavicle fractures, in order to objectively evaluate all current surgical techniques used across Canada. This pragmatic approach will allow us to observe surgical decision-making, rationale for implant removal, and report on clinical, radiographic, and patient-reported outcomes for all techniques over a 2-year follow-up timeframe, for the first time.

All enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively. This will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Treated with surgical fixation for a displace mid-diaphyseal clavicle fracture.
* Aged 18 years of age or older and skeletally mature.
* Enrolled within 21 (+3 days) of injury.
* Willing and able to complete consent and study participation.

Exclusion Criteria:

* Pathological fractures.
* Clavicle non-unions.
* Current or prior ipsilateral upper extremity injury that may impact functional outcomes.
* Polytrauma patients with injuries projected to affect rehabilitation course.
* Active malignancy.
* Inability to provide consent or complete follow-up.
* Incarcerated patients.
Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth

The proposed study will test the following hypotheses:

1. Pre-operative daily dual supplementation with Juice Plus+ (fruit \& vegetable) for 11 weeks will result in reduced post-operative morbidity in terms of quality of life, pain and trismus after 1 week following surgical removal of lower third molars, when compared to placebo.
2. Pre-operative daily dual supplementation with Juice Plus+ (fruit \& vegetable) for 11 weeks will reduce serum markers of oxidative stress, following surgical removal of lower third molars, when compared with placebo.

In general antioxidant status appears to influence wound healing in humans and in animal models of acute trauma, with low antioxidant concentrations and excessive oxidative stress being associated with impaired healing. Whilst antioxidant supplementation has been reported to improve plasma antioxidant status and wound healing in animal models of acute trauma, there is remarkably little data from human studies.

The use of Juice Plus+ has been reported to increase serum concentrations of important antioxidants and reduce serum markers of oxidative stress. However, to date there are no reported studies concerning the potential for Juice Plus+ to improve patient-based outcome measures following the surgical removal of lower third molars. This study therefore proposes to investigate the impact of daily supplementation with Juice Plus+, in improving outcomes following surgical trauma. While the rationale for the proposed study is primarily predicated on the established role of oxidative stress and antioxidant micronutrients in chronic inflammatory diseases, the proposed randomized controlled clinical study represents an efficient way of evaluating the potential for adjunctive Juice Plus+ use in improving wound healing and reducing post-operative morbidity following surgical procedures on humans.

Eligibility Criteria:
Inclusion Criteria:

1. Patient requiring surgical removal of a single (unilateral) mandibular wisdom tooth
2. Tooth requiring full mucoperiosteal flap to be raised for removal
3. Bone removal necessary during procedure.

Exclusion Criteria:

1. Patients refusing to give written informed consent
2. Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
3. Pregnant or breast-feeding women
4. Patients taking long term anti-microbial or anti-inflammatory drugs
5. Patients unable to swallow Juice Plus capsules
6. Patients taking regular vitamin or mineral supplementation
7. Patients requiring pre-operative antibiotics for surgery
8. Patients requiring concomitant extractions or contralateral lower 3rd molar removal
9. Allergic to any of the ingredients contained in supplements or placebo medication.
Postprandial Effects of a High Potassium Meal

The investigators aim to evaluate the acute effects of potassium supplementation achieved by ingestion of potassium rich food, on vascular health.

Many studies have shown that an increase in potassium through the diet or through potassium pills helps to lower blood pressure. Also, the amount of oral potassium taken can improve how well the participants blood vessels work. These studies have focused on potassium given in the form of a pill. The investigators are interested in the effect of potassium consumed through food sources and how it will effect arterial health and blood pressure. The world health organization (WHO) recommends a K⁺ intake of at least 3510 mg/day from food for adults, excluding those with impaired K⁺ excretion. In this study the investigators aim to provide approximately 75% (approximately 2000 mg) of the total daily recommended intake for potassium in one meal. The investigators do not know whether dietary potassium (not pill form) will acutely improve the arterial health and if it will cause a decrease in blood pressure. The investigators hypothesis to see an improvement in vascular function following a high potassium meal compared to a low potassium meal.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* Normal sinus rhythm
* A diagnosis of hypertension on medical therapy with an ambulatory systolic blood pressure \<160 mmHg and diastolic blood pressure \<90 mmHg, or a diagnosis of stable coronary artery disease

Exclusion Criteria:

* Recent hospital admission due to an cardiovascular events
* Serum K+ concentration \>5.0 mmol/L
* Current smoking
* Women who are pregnant
* Diabetic patients - patients receiving insulin therapy
* Glomerular filtration rate \< 90mls/min/1.73m2
* On loop diuretic therapy
* Food allergies and/or intolerance to meal items
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* present with type 2 diabetes mellitus
* HbA1c between 7.1% and 11.0% inclusive
* body mass index (BMI) of \>18kg/m2 and \<35kg/m2, inclusive
* treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start

Exclusion Criteria:

* Have received chronic (\>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
* Have been treated with drugs that promote weight loss within 90 days prior to study start.
* Have been treated with drugs that directly affect gastrointestinal motility for \> 21 consecutive days within 90 days prior to study start.
* Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
* Have been treated for \>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
* Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
* Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
* Have donated blood within 30 days prior to study start.
Effects of Thrower's Ten and Routine Physical Therapy in Patients With Shoulder Impingement Syndrome

To compare the effects of thrower's ten and routine physical therapy on pain, range of motion and functional disability in patients with shoulder impingement syndrome

Shoulder impingement is a common cause of shoulder pain. It's also known as impingement syndrome or swimmer's shoulder, since it's common in swimmers. It occurs when there is impingement of tendons or bursa in the shoulder from bones of the shoulder. A randomized clinical trial will be conducted at Ibne Sina Hospital,Multan . Non probability convenience sampling technique will be applied on 46 patients who will be allocated through computerized randomization into group A \& group B to collect data. Group A will be given Throwers ten Program and group B will be given routine physical therapy along with baselines. The study will be completed within the time duration of nine months. Primary Outcome measures of the research will be pain, range of motion,function and disability . Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age group 18-35 years
* Male and female
* Shoulder or neck pain within the prior 6month
* 3 positive tests out of 5: Positive Neer's test, positive Hawkins test, positive Jobe's test, painful arc, and pain on resisted external rotation of the arm.

Exclusion Criteria:

* History of surgery of the affected shoulder
* Fractures in around the shoulder
* Neurological disorders leading to altered muscle activity
* Systemic arthritic conditions (RA, Osteoporosis)
* Disorders of the cervical spine
Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.

Perioperative anxiety in children is a common multifactorial influenced and triggered entity with an incidence as high as 50%. Especially (mask)induction of anesthesia is considered one of the most stressful experiences for a child undergoing surgery. A common practice worldwide to diminish the level of anxiety prior to anesthesia is premedication with the benzodiazepine midazolam in order to improve cooperation during induction.

Premedication with midazolam has a primary purpose to reduce preoperative anxiety and has inherent to a benzodiazepine its sedative effects. Although these effects are implied, negative effects of premedication: respiratory complications, paradoxical negative behavior has been reported. Although alternative medications have been studied, studies for non-pharmacological anxiety-reduction remain limited.

Non-pharmacological anxiety-reduction by distraction including Tablet or IPAD-multimedia might be a readily available alternative for midazolam premedication. Potentially limiting the use of psychoactive agents, limiting the need for preoperative sedation and therefore possibly decrease secondary respiratory complications in pediatric surgical day-care.

Objective:

The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the mask-induction of anesthesia. Secondly to evaluate the need for midazolam premedication in pediatric day-care surgery patients induced by inhalational anesthesia.

Eligibility Criteria:
Inclusion criteria

* Age ≥ 1 year and \<8 years old
* ASA class 1 or 2 (American Society of Anesthesiologists Physical Status Classification System)
* Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
* Written informed consent by the legal parents or caretaker

Exclusion criteria

* Parents of the patient wish not to participate with the study
* Parents are not able to give informed consent (language barrier, legally incapable)
* A contraindication for the use of premedication with midazolam
* A known allergy to midazolam
* A contraindication for premedication in general
* A contraindication for the use of a gas-induction/gas-anesthesia
* A contraindication for the use of sevoflurane
* A known mental retardation of the child
* Preoperative behavioral disturbances and psychiatric disorders
* Any use of psychoactive medication
* A known photosensitive epilepsy
* A previous operation within 3 months of the time of scheduled operation
* Any other contraindication for the use of the study medication
* Previous history of multiple surgery (\>3)