cyrilzakka/clinical-trials huggingface dataset:
Family Based Treatment of Depressed Adolescents

The purpose of this project is to assess the effectiveness of a family-based therapy (Attachment based family therapy-ABFT) for Norwegian adolescents (13-17 years) referred to specialist mental heath clinics.

Depression is a major public health concern among adolescents. Research suggests that it not only is prevalent among adolescents (as many as 20% of adolescents have a depressive episode by the age of 18), but its effects last well into adulthood. Although available studies of psychosocial and pharmacological interventions show promise, there are concerns regarding their effectiveness and possible side effects like increase in suicidal ideation. Family conflict is not only an effect of depression, but also a risk factor for depression. High conflict and dysfunction, have consistently been shown to increase risk for depression. As such, family treatments that target risk and protective factors (e.g., quality of parent-child interaction, parental monitoring) for depression seem promising to reduce depression. The current study is a randomized clinical trail aimed at assessing the effectiveness of a 12-week family based intervention for depressed adolescents (Attachment based family therapy- ABFT). Adolescents referred to specialist mental health hospital in south-west Norway (Stavanger University Hospital) will be randomized to either ABFT or treatment as usual (TAU). Therapists administering both the experimental and control group intervention are regular staff clinicians. Outcome assessments would be carried out at baseline, 6, 12 and 26 weeks by raters blind to the condition of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* 13-17 years
* Referred to specialist mental health hospital
* HAM-D score of \>14
* Meets diagnostic criteria for major depressive disorder or depression NOS
* Have a parent or guardian willing to participate

Exclusion Criteria:

* Suicidal and require in-patient care
* Low intellectual abilities
* Current psychosis
* primary caregiver unwilling to participate
Activities of Daily Living and Upper Extremity Exercise Capacity of Individuals with High Body Mass Index

Individuals with high and normal body mass index will be included in this study.


Eligibility Criteria:
Inclusion Criteria for individuals with high body mass index:

* Body mass index ≥ 25 kg/m2
* Volunteering for the study

Exclusion Criteria for individuals with high body mass index:

* Having uncontrolled hypertension, diabetes mellitus
* Having comorbidities that may affect physical functions
* Failure to cooperate with tests to be performed
* Liver disease, kidney disease, cancer, lung diseases and serious cardiomyopathies, neurological diseases
* Pregnancy
* Having a history of bariatric surgery
* Presence of contraindications to exercise testing

Inclusion Criteria for individuals with normal body mass index:

* Body mass index 18.5-24.9 kg/m2
* Volunteering for the study

Exclusion Criteria for individuals with normal body mass index:

* Body mass index \> 25 kg/m2 or ≤18.5 kg/m2
* Having a known chronic or systemic disease
* Failure to cooperate with tests to be performed
Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity

Obese persons are known to have elevated levels of parathyroid hormone (PTH) and low levels of vitamin D. These hormones are important in regulation of the body's calcium stores and bone health. We would like to investigate these abnormalities and the accuracy of our current diagnostic tests by comparing results of standard assays for vitamin D and PTH to more specific tests, in obese subjects at baseline and as vitamin D is replaced. We will also compare two standard vitamin D replacement regimens to determine if one is more effective.

This is a pilot study with two parts: Part 1 will compare levels of PTH and vitamin D using two different assays in obese subjects who have normal vitamin D and those who do not. We plan to enroll 20 subjects who have normal vitamin D levels and 40 subjects who have vitamin D insufficiency. All subjects will fill out questionnaires about the amount of calcium and vitamin D in their diet, and their recent sunlight exposure. We will ask for blood samples so that we can measure levels of calcium, vitamin D, albumin, creatinine, glucose, insulin and the different forms of PTH.

Subjects who have vitamin D insufficiency will then be randomized to receive Vitamin D2 or Vitamin D3 in standard doses for eight weeks, in an open label trial. At four and eight weeks, these subjects will fill out the above questionnaires and have the blood tests repeated. For safety purposes, urine calcium will also be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Obese subjects with body mass indices greater than 40 kg/m2 or 35 kg/m2 with other medical conditions secondary to obesity
* Willingness to take vitamin D supplements
* If baseline vitamin D level is \>25 ng/ml subjects will be eligible for the control group
* If baseline vitamin D level is \<25 ng/ml subjects will be eligible for one of the two vitamin D replacement groups

Exclusion Criteria:

* Hypercalcemia
* Kidney disease
* Liver disease
* Malabsorption
* Prior diagnosis of bone disease
* Medical conditions requiring daily use of calcium, antacids, or medications known to affect bone metabolism or interact with vitamin D
* Hypersensitivity to any formulation of vitamin D
Comparison of Aurora Fundus Camera With Traditional Camera in Diabetic Retinopathy With Visual Artificial Intelligence

This study aims to compare the effect of Aurora handheld fundus camera with traditional desktop fundus camera in the fundus photography screening of diabetic patients, and to evaluate the effect of artificial intelligence algorithm in the diagnosis of diabetic retinopathy.

Aurora handheld fundus cameras are used to take fundus photography on diabetic patients in 3 ophthalmic diabetic retinopathy screening centers in China to compare its effect with the hospital's traditional desktop fundus camera, and evaluate the auxiliary diagnostic effect of Phoebus artificial intelligence algorithm in diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Participants are more than 18 years of age, male or female Chinese patients;
2. Diagnosed with diabetes;
3. Prior written informed consent should be obtained

Exclusion Criteria:

1. Patients with invisible fundus caused by any cause;
2. Patients or his/her licensor unwill to sign an informed consent or follow this protocol;
3. Pregnant women
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

The CryoValve SG pulmonary human heart valve is recovered from deceased human donors, treated with the SynerGraft® process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve.

Eligibility Criteria:
• Retrospective Patients

o Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction between February 2000 and March 2004 who were included in the 510(k) data collection will be identified using the following general criteria to aid in selection of patients who are most likely to provide adequate follow-up data: Patient is alive and the implanted valve is still in place (has not been explanted).

Patient is still under the care of the implanting institution or the implanting surgeon.

Patient was identified as previously providing data for at least one echocardiographic follow-up assessment at a minimum of one year post-implant.

* Additionally, prospective enrolling centers will have the option to enroll retrospective patients. At these centers, all consecutive patients identified from valve implant data at CryoLife, implanted with a CryoValve SG Pulmonary Valve as a valved pulmonary valve prior to Clearance in 2008 will be targeted for inclusion in the retrospective patient data collection.

  • Prospective Patients
* Sequential patients implanted with a CryoValve SG Pulmonary Human Heart Halve as a Ross or RVOT reconstruction after FDA 510(k) clearance in February 2008 at selected institutions.
Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers

This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer.

The primary purpose of this testing is to determine the presence of 12 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, KRAS G12C and HER2, rearrangements in ALK, RET, NTRK, EGFR exon 20 insertion and ROS1, and amplification of MET and HER2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected.

Thoracic Surgery Oncology Group (TSOG) is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer. TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial. TSOG's involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study. We estimate we will detect an actionable oncogenic driver in 33% of cases. The remaining 66% of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents.

The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial, evaluating for efficacy. If none of the 10 oncogenic drivers are detected, the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy. For patients not enrolled on a targeted treatment trial, circulating tumor DNA in blood (ctDNA) will be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. This initiative will be correlated with various clinical outcomes. Prespecified clinical data will be collected for correlation with these circulating biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Clinical stage IA2-III lung cancers
* Potentially resectable if lung cancer suspicion confirmed pathologically
* Operable

Exclusion Criteria:

* No concurrent malignancy
* No prior lung cancer within last 2 years
* Purely ground glass pulmonary opacity
Pain Assessment in the Perioperative Area

This study is mainly focusing on reducing the pain scores during IV cannulation in pediatric population in the preoperative period. Applying EMLA cream is a well-known fact world wide. we would like to study the effect of ultrasound waves in the penetration of the given drung into the skin so that we could achieve the effect of the drug quickly.

To assess the intensity of pain in children in the perioperative area during IV cannulation using a combination of EMLA cream and low-frequency USG probe. To assess the intensity of pain in children in the perioperative area during IV cannulation using a combination of EMLA cream and high-frequency USG probe and final comparison between these groups will assess the effect of ultrasound in the penetration of the drug into the skin.

Eligibility Criteria:
Inclusion Criteria:

* All children in the preoperative period.

Exclusion Criteria:
ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P) product.


Eligibility Criteria:
Inclusion Criteria: - On hemodialysis for at least 3 months and have received intravenous vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to entering screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months and corrected serum Ca greater than 8.4 mg/dl within 2 months prior to screening period. For subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55 mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH 80-430 pg/ml and a corrected serum Ca level greater than 8.4 mg/dl. For subjects with biPTH 80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH (post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8.4 mg/dl Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - Use of investigational drug or device or participation in a trial of investigational drug or device within 30 days of screening - Females of child bearing potential who are pregnant (e.g., positive pregnancy test) or are breast feeding or who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study - Previously participated in this or any other Sensipar® study or has received or is receiving Sensipar® as a commercially available product
Brain Blood Flow: Age and Gender

Baseline cerebral blood flow through the middle cerebral artery (MCA) and cerebral vasodilator response of the MCA to inhaled carbon dioxide (CO2) will be measured in young women, young men, older women, and older men using Magnetic Resonance (MR) imaging and transcranial Doppler ultrasound (TCD). Data collection techniques will be compared.

The investigators have recently shown that cerebral blood flow responses to chemical stimuli are reduced in healthy older adults. The investigators also have preliminary data suggesting that sex differences in cerebrovascular regulation exist. The overall goal of this application is to extend on the investigators previous studies by employing advanced neuroimaging techniques to enhance the investigators understanding of neurovascular coupling in healthy aging. This study will collect clinically significant data with implications for the future risk of cognitive decline and Alzheimer's disease.

The research aims are:

1. To determine the effect of age and sex on baseline cerebral blood flow through the middle cerebral artery (MCA).
2. To determine the effect of age and sex on cerebral vasodilator responses.
3. To determine if the cerebrovascular responses measured by transcranial Doppler ultrasound (TCD) are associated with the cerebrovascular responses measured by Magnetic Resonance (MR) imaging.

Eligibility Criteria:
Inclusion Criteria:

* Between 20-34 or 50-69 years
* Body mass index \<34 kg/m2

Exclusion Criteria:

* Current smoker
* History or evidence of: hepatic disease, renal disease, hematological disease, peripheral vascular disease, stroke/neurovascular disease, diabetes, hypertension
* Part of a vulnerable population (e.g. pregnant women, prisoner, individuals lacking capacity to consent, etc.)
* Older females only: subject is not post-menopausal
Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Block

This study is designed to investigate the analgesic efficacy of ketamine compared to neostigmine as adjuvants to LA in ultrasound guided Serratus Anterior Plane Block (SAPB) in patients undergoing Modified Radical Mastectomy. We hypothesize that adding either neostigmine or ketamine to bupivacaine in ultrasound guided SAPB would increase the total analgesic duration and decrease the total 24 hr postoperative Nalbuphine consumption compared to SAPB with bupivacaine only. The first 24 hr of postoperative Nalbuphine consumption is set as the primary outcome. The time of the first request of analgesia, pain score, side effects of drugs and patient hemodynamics are set as the secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* ASA II patients, BMI\< 35Kg/m2

Exclusion Criteria:

* refusal of participation, ASA III or above, history of allergy to the study drugs, BMI\> 35kg/m2, coagulation disorders, psychiatric illnesses that may interfere with pain evaluation, epileptic patients, patients with tachy or brady arrthymias, patients with increased intracranial tension
Study on the Outcome of Treatment of Rotator Cuff Injury by Ultrasound-guided Injection

Rotator cuff injury is a common shoulder joint disease in clinic. If conservative treatment fails to improve pain symptoms and range of motion, the surgical indications are. Numerous studies have shown that the pain of rotator cuff injury usually comes not from the broken tendon, but from periarthritis tendonitis, bursitis or adhesive shoulder capsule, etc. Ultrasound-guided drug injection combined with conventional rehabilitation treatment can significantly improve the pain symptoms and increase joint mobility. This study intends to use prospective cohort study methods, exposed factors for ultrasound-guided injection drug treatment, establish a rotator cuff injury exposure group and the control group of shoulder joint dysfunction queue, whether of ultrasound guided drug injection therapy can increase the shoulder joint function analysis, and explore for the rotator cuff injury method provides the basis of the evidence-based conservative treatment. The establishment of a conservative treatment cohort for rotator cuff injury will also lay the foundation for the accurate rehabilitation treatment of rotator cuff injury.


Eligibility Criteria:
Inclusion Criteria:

* Chief complaint around shoulder joint discomfort or restricted movement
* Nuclear magnetic or ultrasound in the diagnosis of rotator cuff injury and not to consider surgery patients
* Assessed by the musculoskeletal ultrasound images, diagnosed with tendonitis around shoulder joint, slippery bursa phlogistic or adhesive shoulder level
* Section capsule, such as indications of patients treated with ultrasound guided by injection.

Exclusion Criteria:

* History of shoulder fractures, open trauma, or surgery combined with shoulder and hand syndrome, gout, autoimmune arthritis, infectious arthritis, and other factors resulting in shoulder pain or limited mobility
Treatment for Whiplash Injury

Objective: Cervical facet joint (CFJ) pain is commonly seen after whiplash injuries, and is frequently refractory to physical therapy and oral medication. The investigators will evaluate the effectiveness of intra-articular corticosteroid injection for managing whiplash-related CFJ pain.

Methods: The investigators will recruit 32 patients with chronic and persistent CFJ pain (≥ 3 on the Numeric Rating Scale \[NRS\]) despite physical therapy and oral medication. Under fluoroscopy guidance, The investigators will inject 10 mg (0.25 mL) of triamcinolone acetonide, mixed with 0.25 mL of 0.125% bupivacaine and 0.5 mL of normal saline. At 1 and 2 months after the injection, pain intensity will be reassessed using the NRS.


Eligibility Criteria:
Inclusion Criteria:

* history of a traffic accident
* ≥ 3-month history of axial cervical pain after the accident without radicular symptoms
* whiplash-associated disorder (WAD) severity of Grade II (neck complaint, decreased range of motion of neck, and point tenderness) at first hospital visit
* failure to respond to physical therapy and oral medication (axial cervical pain of ≥ 3 on the numeric rating scale (NRS 0-10; 0, no pain; 10, worst pain imaginable)
* ≥ 80% temporary pain relief following a diagnostic block with an intra-articular (IA) injection of 0.3 mL of 2% lidocaine

Exclusion Criteria:

* presence of cervical spine fracture, coagulopathy, iodinated contrast allergy, rheumatic disorders, and any uncontrolled medical or psychiatric condition
Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression

This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.

Some people with depression do not respond well to antidepressant treatment. S-adenosyl methionine (SAMe) is a naturally occurring compound that may have antidepressant effects. SAMe may also enhance the effectiveness of other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs). This study will determine the effectiveness of oral SAMe in enhancing the effects of SSRIs in patients currently not responding to SSRI treatment.

This study will last 6 weeks. No follow-up visits will occur. Participants will be randomly assigned to add either oral SAMe or placebo to their existing SSRI regimen for 6 weeks. Depression scales and self-report questionnaires regarding depressive symptoms will be used to assess participants at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive disorder
* Use of an SSRI for at least 6 weeks prior to study entry with partial or no response

Exclusion Criteria:

* History of psychosis
* Allergy to SAMe
* Alcohol or drug abuse in the past 3 months prior to study entry
Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte donation with the following characteristics:
* Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
* \>=18 and \<35 years old;
* Regular menstrual cycle (26 - 35 days);
* BMI between 18 and 30 kg/m2;
* First gonadotrophin treatment (i.e. naïve Subjects with regard to exposure to human derived or recombinant gonadotrophins);
* basal FSH \<10 IU/L and E2 \<80 pg/ml (\~290 pmol/l);
* Normal TSH levels;
* Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out period of two months).

Exclusion Criteria:

* Age \<18 and \>=35 years;
* PCOS;
* Endometriosis;
* Subjects with evidences of autoimmune or rheumatic diseases;
* Hypersensitivity to the active substance or to any of the excipients (lactose);
* Abnormal bleeding of undetermined origin;
* Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal diseases);
* Uncontrolled adrenal dysfunction;
* Neoplasia;
* Severe impairment of renal and/or hepatic function;
* Use of concomitant medications that might interfere with study evaluations (e.g. immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin, growth hormone...).