cyrilzakka/clinical-trials huggingface dataset:
Child and Adolescent OCD Outcomes From Exposure and Response Prevention Video Teletherapy Treatment

This is a naturalistic, observational study of children and adolescents with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy.


Eligibility Criteria:
Inclusion Criteria:

* obsessive-compulsive disorder

Exclusion Criteria:

* none
Long Term Follow up of Patients Who Were Treated With Extracorporeal Membrane Oxygenation for Pandemic Influenza A/H1N1 Induced Severe Respiratory Failure

Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or circulatory failure show severe long term disability due to impaired lung -, cerebral-, cognitive function and impaired quality of life. This study investigates the long term outcome of all patients who are still alive three years after ECMO treatment for severe respiratory failure during the H1N1 2009 pandemic at the Karolinska University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Survivors of ECMO treatment for influenza a/h1n1 pneumonia during 2009/2010 pandemics at the ECMO Center Karolinska

Exclusion Criteria:

* None
Shoulder Muscle Massage Shoulder Stiffness

The investigators investigated the effect and predictors of effectiveness of massage in the treatment of patients with posterior shoulder stiffness. This is a randomized controlled trial study- massage and control (hand touch) two times a week for 4 weeks. A total of 60 patients with posterior shoulder tightness were randomized into 2 groups; 52 of them completed this study (29 for the massage and 23 for the control). Patient sex, age, body mass index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional status, and muscle stiffness were recorded. Additionally, for the massage group, patients with glenohumeral internal rotation improvement of 20 degrees after massage were considered responsive, and the others were considered nonresponsive. The influences of the aftermentioned factors on the effectiveness of massage were analyzed by multivariate logistric regression. The overall mean internal rotation ROM increased significantly after massage (from 31.9° to 54.9°; P \< 0.001) compared to the control (from 28.7° to 34.9°; P \> 0.05). There were 22 patients in the responsive group and 7 in the nonresponsive group. Among the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were significant predictors of effectiveness of massage. Massage was an effective treatment for subjects with posterior shoulder stiffness, but was less effective in patients with longer duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.


Eligibility Criteria:
Inclusion Criteria:

1. a limited ROM of internal rotation (internal rotation ROM \< 20% to the sound side), and
2. pain and stiffness in the shoulder region for at least 3 months.

Exclusion Criteria:

1. surgery on the particular shoulder,
2. rheumatoid arthritis,
3. stroke with residual shoulder involvement,
4. fracture of the shoulder complex,
5. rotator cuff deficiency, and
6. resting pain, intolerable pain, or muscle spasm during active and/or passive motion.
Intensity-modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) for Inoperable Non-small-cell Lung Cancer

Lung cancer is one of the most common cancer and the leading causes of cancer death in worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Lung cancer is one of the most common cancer and the leading causes of cancer death in patients worldwide. Approximately 80% of NSCLC were inoperable. Concurrent chemo-radiation therapy (CCRT) is a standard treatment for locally advanced NSCLC who are not candidates for surgery. Nevertheless, the prognosis of patients with locally advanced NSCLC (LA-NSCLC) is still poor. Local control (LC) after CCRT is one of the most important prognostic factors. Local failure is common after standard-dose chemoradiation for NSCLC. Studies of stereotactic body radiation therapy (SBRT) have shown a steep dose response in treating early-stage lung cancer. Improving the total dose and shortening the overall treatment time may be effective for improving the LC rates. However, problems remain due to the toxicity to adjacent critical structures (e.g,lung,heart, esophagus), the target volumes usually limits the doses escalated that cannot be safely delivered by conventional radiotherapy techniques. In order to avoid the acute and late radiation toxicity of normal tissues, different dose prescriptions can be delivered to different target volumes in the same fraction, which deliver a higher dose to the Gross Tumor Volume (GTV) and a relatively lower dose to the subclinical disease. The technique is called simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT).

Investigators hypothesized that use of SIB-IMRT technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed NSCLC, inoperable stages IIA-IIIB, according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
2. Performance status 0 to 2, ≤5% weight loss within the past 6 months
3. A forced expiratory volume at 1 second of ≥ 1 L
4. Life expectancy \> 3 months
5. No invasion of large vessels, heart, esophagus, spinal cord.
6. Based on conformal treatment planning, the volume of lung at or exceeding 20 Gy (V20) must have been≤30%, the mean esophagus dose≤34 Gy, and the volume of esophagus exceeding 55 Gy (V55)≤30%
7. Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
8. Without severe other diseases
9. Informed consent

Exclusion Criteria:

1. Had received prior thoracic radiotherapy
2. Supraclavicular lymph node metastasis, pleural or pericardial effusions, and superior vena cava syndrome
3. Pregnant and lactating women
4. Serious complications
5. Other primary malignancies
Autism Spectrum Disorders (ASD) Characterization Study

The overarching aim of the study is to characterize children and adults with ASDs, and compare them with age-matched controls in relation to their functioning in family, academic, employment, and social spheres. Subjects will be comprehensively assessed in multiple non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial instruments.


Eligibility Criteria:
Inclusion Criteria:

* Age: 6-60 years old
* For subjects who have ASD: Meet DSM-IV PDD criteria based on clinical assessment including PDD module of structured interview
* For subjects who have ASD: One parent/guardian available for interviews about each subject. If a parent or guardian is not available, a reliable adult reporter identified by the subject available for an interview
* Full-scale IQ of above 80

Exclusion Criteria:

* Major sensorimotor handicaps (e.g. deafness, blindness)
* Any severely unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, substance use disorders (alcohol or drugs) that would require in-patient hospitalization.
* Inadequate command of the English language.
Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals

The fact that changes in plantar pressure during walking and in a fixed position in morbidly obese individuals and the relationship between postural oscillations and balance have not been fully elucidated creates a need in this area.

In this study, primary aim is to investigate the change in plantar foot pressure, balance parameters and the relationship between them in morbidly obese individuals compared to healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-60
* BMI ≥ 40 kg/m2, morbidly obese individual
* No surgical operation in the last 6 months
* Non-obese healthy adult individuals will be included in the study as the control group.

Exclusion Criteria:

* Having a musculoskeletal disorder or systemic disease that will interfere with physical activity
* Presence of balance problems that will prevent physical activity
* Presence of psychiatric or neurological disease affecting cooperation and cognitive functions
* Presence of acute pain
* Presence of uncontrolled diabetes and hypertension
* Having any communication problems
Impact of COVID-19 Pandemic on Depression and Quality of Life

It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them

Study hypothesis that people are tend to be depressed and the quality of life is affected negatively by Covid-19 pandemic. Although Turkey has affected moderately, the immediate change on depression and quality of life observable and measurable. It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them. According to existing data and perspective of psychology and physiotherapy, potential solutions will be aligned.

Eligibility Criteria:
Inclusion Criteria:

* being Turkish
* understanding Turkish
* currently living in Turkey
* being between the age of 15 - 65
* being literate
* have internet access

Exclusion Criteria:

* being diagnosed with a psychological disorder before the pandemic
* having missing value on outcome measures
* giving incomprehensible answering
Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting

The purpose of the study is to assess the feasibility of identifying, recruiting and randomizing a large sample of Danish citizens aged 65-79 years to high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine in the 2021/2022 influenza season in a registry-based setting using Danish nationwide registries for all data collection including baseline information and outcome assessment.

To evaluate the feasibility of recruiting and randomizing Danish citizens aged 65-79 years, we aim to randomize 40,000 citizens 1:1 to high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine in a pragmatic, open-label, registry-based design using the infrastructure of Danske Lægers Vaccinations Service (DLVS), an organization responsible for numerous vaccination clinics in Denmark, for recruitment and randomization and Danish nationwide registries for data collection. Citizens will be recruited by DLVS and randomized and vaccinated at the DLVS clinics. All collection of data related to baseline information, outcomes, and safety monitoring will be performed by a central trial site utilizing information from Danish nationwide health registries.

The findings of this pilot trial will indicate whether the conduction of a full-scale, adequately powered pragmatic RCT is feasible within the Danish registry-based framework.

Eligibility Criteria:
Inclusion Criteria:

1. Age 65-79 years
2. Informed consent form has been signed and dated

Exclusion Criteria:

1. Allergy/hypersensitivity towards the influenza vaccines used in this study
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants with Primary Immunodeficiency

This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
2. Participant for whom study drug is entered in the therapeutic drug field on the data set.
3. Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
4. Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.

Exclusion Criteria:

1. Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029.
2. Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
3. Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
Monitoring Noninvasively for Infusion and Transfusion Optimization

This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of consent.
* Ability to provide written informed consent.
* Scheduled for non-urgent major surgery with general anesthesia
* At least one finger available and accessible for performing non-invasive pleth variability index (PVi) and hemoglobin (SpHb) monitoring.
* The Attending surgeon, attending anesthesiologist and the clinical care team agree with enrollment in the study, including the restrictions on monitoring procedures defined in the control group.

Exclusion Criteria:

* Untreated or uncontrolled hypertension defined as mean arterial pressure (MAP) greater than 120 mmHg, despite medications.
* Chronic kidney disease with glomerular filtration rate \<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease.
* Surgeries where no bleeding is expected to occur (i.e., total knee surgery where blood loss is prevented by use of tourniquet).
* Surgeries performed in the prone position.
* Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome.
* Aortic pathology that could lead to misinterpretation of hemodynamic variables (e.g. intra- aortic balloon pump, thoracic aorta aneurysm).
* Renal vascular surgery.
* Preoperative sepsis.
* Circulatory shock.
* Preoperative vasoactive substance infusion before study entry.
* Concurrent participation in any interventional study.
* Pregnant or lactating women.
* Patients who refuse to receive blood transfusion(s).
* Patients with Do Not Resuscitate (DNR) orders.
* Open chest surgeries.
* Prisoners
* Patients for whom monitoring of CO, SV, PPV, and/or SVV to guide GDT or similar intra-operative fluid management, including continuous SpHb monitoring, would be standard of care.
* Patients have skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors.
* Cardio-pulmonary bypass (CPB) surgery.
Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)

The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
* Tolerating primary study therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers

To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 18.5 and ≤ 30.0 kg/m2.
* No clinically significant findings in a 12-lead electrocardiogram (ECG)
* Age 18-60 years at screening

Exclusion Criteria:

* History of severe allergy or allergic reactions to the IMPs or related drugs
* History of serious clinical illness that can impact fate of drugs including major surgery
Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect

Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density

: Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.

Eligibility Criteria:
Inclusion Criteria:

• Presence of at least one tooth with PPD and CAL loss of ≥ 5 mm associated with an intra-bony defect of ≥ 2 mm according to Cortellini and Tonetti, 2007

Exclusion Criteria:

* Patients with uncontrolled or poorly controlled diabetes, life-threatening conditions, or requiring antibiotic prophylaxis were excluded.
* Smokers
* Pregnant patients.
* Patients with aggressive periodontitis.
* Patients with multiple interconnected vertical defect walls.
Low Level Laser Therapy in the Dorsal Root Ganglion in the Treatment of Chronic Low Back Pain

Chronic axial low back pain is a public health problem and has a high socioeconomic impact. The dorsal ganglion of the second spinal nerve (GDL2) is a cluster of neuronal bodies responsible for sensory afferent inputs from more than 80% of the lumbar region. Low-level laser therapy (LLLT) is proven effective to help relieve pain. Thus, the aim of this project is to determine the effect of LLLT on GDL2 when applied to assist in the diagnosis and treatment of chronic axial low back pain. Methodology: 45 patients will be randomized into three groups: laser, radiofrequency and local anesthetic. The patient will be positioned in a prone horizontal position under anesthetic monitoring. The intervertebral foramen between the second and third lumbar vertebrae will be accessed by percutaneous puncture guided by fluoroscopy. In the local anesthetic group, injection of 1 ml lidocaine without vasoconstrictor will be applied in the tubes G20, 150 mm long and 5 mm active tip in contact with the target. In the radiofrequency group, neuromodulation will be held for 300 seconds at 42oC. In the laser group, the laser Photon III® (DCM) will be applied through optic fiber crossing G18 cannulas, during 84 seconds. The pain score will be assessed by visual analog scale. Temperature will be measured and aspirate periganglionic sample, trans-operatively, to study Interleucins-1β and TNF-alpha assessed by ELISA and genetic evaluation trough RNA seek, RNA isolation and ATP quantification. The data will be evaluated for normality and subjected to appropriate statistical analysis, in order to seek representation, as same as the level of significance of the studied samples.


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain (more than 3 months of nociceptive or neuropathic pain).
* No neurological deficits

Exclusion Criteria:

* Active lumbar cancer
* Active infection
* Coagulation disorders
Gamified Adaptive Approach Bias Modification on Individuals With Methamphetamine Use History

A randomized controlled trial will be conducted to investigate whether a proposed algorithm that adjusts the congruency ratio based on the user's performance and difficulty can enhance the effectiveness of approach bias modification. Methamphetamine users will be recruited and randomized into an algorithm group, a standard group, and a control group.

To assess the efficacy of an adaptive approach bias modification (A-ApBM) paradigm with gamified designs and dynamic difficulty adjustments in reducing cue-induced craving in individuals with methamphetamine use history. DESIGN: Randomized controlled trial with three study groups: Adaptive ApBM (A-ApBM), Static ApBM (S-ApBM), and control. A-ApBM and S-ApBM groups engaged in ApBM training using a smartphone application for four weeks. A-ApBM used an adaptive algorithm to dynamically adjust the difficulty level based on individual performance, while S-ApBM had a static difficulty level. Cue-induced craving scores were assessed using a visual analog scale at baseline, post-intervention, and at week-16 follow-up.

Eligibility Criteria:
Inclusion Criteria:

• having a history of methamphetamine use of at least one year

Exclusion Criteria:

* could not fluently operate an Android or an iOS smartphone
* having mental health conditions other than MUD
Paired Acute Invasive/Non-invasive Stimulation Trial

Chronic pain patients with implanted dorsal root ganglion stimulators will be randomized to receive transcranial direct current stimulation (tDCS) to the motor cortex, magneto-encephalographically (MEG) localized stimulation or sham stimulation to identify therapeutic efficacy of paired central and peripheral neuromodulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing and able to give consent to the study.
* Male or Female, aged 18 years or above with diagnoses of chronic pain.
* Treatment includes Spinal Cord Stimulation, Dorsal Root Ganglion stimulation, or peripheral analgesic stimulation.

Exclusion Criteria:

* Patients who do not wish to be in the study.
* Patients with metallic intracranial implants.
* Patients with extreme language barrier that cannot understand the purpose of the study despite the use of an interpreter
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery

The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rectal cancer scheduled for robot-assisted rectal resection
* Intact preoperative urogenital/rectal function
* Full capability of consent

Exclusion Criteria:

* Previous/Second malignant disease \<5 years before diagnosis of rectal cancer
* Previous abdominal surgery, except for appendectomy, cholecystectomy or Cesarean section