cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy for Neurotic Disorders: Randomized Controlled Trial

Objective: To evaluate the effectiveness of online systematic brief psychodynamic psychotherapy (SBPP) via HIPAA compliant web conferencing on adults with neurotic disorders.

Design: Randomized controlled trial. Single blind.

Setting: Internet users in the community, in São Paulo, Brazil.

Participants: Thirty-two adults will be randomly allocated to a group will receive online systematic brief psychodynamic psychotherapy (n=16), or a waiting list group (n=16).

Method: Systematic adaptative diagnosis system will be applied in both groups at pre-treatment and post-treatment (or post-waiting list). Assessment will be a comparison of the adaptative diagnosis evolution between groups.

Primary Outcomes: The subjects treated with online brief systematic psychodynamic psychotherapy will present an increase in their adaptative efficacy measured by systematic adaptative diagnosis scale (SADS) in comparison to the waiting list group, when contrasting their initial and final adaptative diagnostics.


Eligibility Criteria:
Inclusion Criteria:

* Residents in Sao Paulo city,
* Graduation complete or in course,
* Fluent Portuguese,
* Basic skills on english language,
* If in psychiatric treatment, must be under treatment with stable dosage of psychiatric medication for at least 6 months,
* Participants with diagnosis of neurotic disorders (F03.650),
* Motivation for the therapeutic process,
* Availability for 4 months of psychotherapy,
* A personal computer (with an IP address), a web camera, a microphone, access to a 1 Mbps internet connection and specific computer configuration to access the Secure Psychotherapy Virtual Environment,
* Basic knowledge of elementary internet tools,
* A justified reason that impedes a in person psychotherapy, such as the ones below:

  * Lack of financial resources,
  * Frequent change of address due to work reasons,
  * Mobility restrictions related to accidents, illnesses or physical deficiencies,
  * Inability to arrive for psychotherapy appointments due to urban chaos.

Exclusion Criteria:

Participants that present:

* a schizophrenia diagnostic or any other severe mental illness,
* drug and alcohol dependence that are in abstinence from substance abuse,
* untreated diagnosis of illnesses that may cause emotional imbalance, such as thyroid malfunction,
* Participants that are undergoing a therapeutic process during the time of the research,
* Individuals with both suicidal ideation and clear intent and need emergency treatment,
* Participants do not possess the characteristics needed to be included in the sample or are bearers of deficiencies that may compromise the treatment mediated by a computer.
Digital Versus Conventional Altered Cast Techniques For Constructing Mandibular Distal Extension Removable Partial Dentures Using Digitally Fabricated Frameworks: Alveolar Bone Height Changes

This clinical study compares between digital and conventional removable partial dentures' construction techniques using digitally approaches regarding their effect on bone height changes of abutment teeth and residual ridge.


Eligibility Criteria:
Inclusion Criteria:

1. All patients having completely edentulous maxilla and class I Kennedy mandible.
2. Sufficient (not less than 15 mm) restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane). This will be detected by a tentative jaw relation.
3. All patients are of angel's class I maxillo-mandibular relationships
4. Abutment teeth must meet certain requirements :

A. Abutment teeth should be healthy with good periodontal and bone support. B. should not show advanced destructions. C. should not show a pronounced degree of mobility or advanced gingival recession.

D. Crown Root Ratio for an abutment is 1:2

Exclusion Criteria:

1. Sever undercuts or concavities on the buccal or lingual sides of the ridge.
2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.
3. History of radiotherapy in the head and neck region.
4. Crown Root Ratio for an abutment is 1:1.
Linkage of Transgender Individuals to PrEP

CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus standard of care (SOC).

Up to 500 self-identified transgender / gender non-conforming persons seeking daily Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV will be enrolled into this study. Each participant will be followed up to 28 weeks after enrollment. The primary endpoint, successful linkage to a PrEP evaluation visit, will be measured after 30 days of enrollment.

Participants expressing interest in PrEP will be referred to the regional transgender PrEP outreach work (T-POWr) via phone call. Enrolled participants will be randomized (1:1) to either SOC PrEP linkage vs T-POWr facilitated PrEP linkage. Participants randomized into the SOC Arm will receive an HIV risk assessment, PrEP education, and an appointment for a linkage visit. Participants randomized into the T-POWr arm will receive SOC and a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services.

Participants will be contacted at Week 4 to verify linkage, and at Weeks 16 and 28 to assess PrEP and HIV status, and access to referred services.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Self-identifies as a transgender or gender non-conforming person
* Self-identifies as HIV-negative or unknown status
* Ability to provide informed consent
* English or Spanish speaking

Exclusion Criteria:

* Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent
Evaluation of the Effectiveness of Vibroacoustic Therapy in the Complex Treatment of Acute Respiratory Failure

Evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure

Assessing the dynamics of changes in physical, instrumental and laboratory parameters in patients with acute respiratory failure taken in the study according to the inclusion criteria and comparing the results with the control group, studying the effectiveness of vibroacoustic lung therapy.

Eligibility Criteria:
Inclusion Criteria:

* adults
* P/F less 300 torr
* ARDS by Berlin convention

Exclusion Criteria:

* children
* acute stroke
* acute coronary syndrome
* DVT
* implanted pacemaker
* rib fracture
* infection on chest
Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria

This is a multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients With PNH who have previously received and completed HSK39297 treatment , and According to the researchers' judgment, the benefits of treatment outweigh the risks and may benefit from continued treatment with HSK39297;
2. Understand the study procedures and methods, voluntarily participate in this trial.

Exclusion Criteria:

1. Hereditary or acquired complement deficiency;
2. Active primary or secondary immunodeficiency;
3. History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
4. History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
5. History of serious comorbidities that have been determined to be unsuitable for participation in the study;
6. Pregnant or Lactating women.
Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels

Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.


Eligibility Criteria:
Inclusion Criteria:

* objective gastroesophageal reflux in adults

Exclusion Criteria:

* esophageal motility disorder
* hard stenosis
* previous antireflux surgery
Adduct Dipstick for Diagnosis of Acetaminophen Toxicity

This study is a non-intervention, clinical study to test "research use only" APAP protein adducts dipsticks in human blood samples. The study will be conducted in two phases. In phase 1, the research use only dipsticks and dipstick testing components will be tested for feasibility in the emergency department at UAMS. Patients will be enrolled that are having an acetaminophen level obtained as part of their medical evaluation. In phase 2, the research use only dipsticks will be tested in centers that participate in the Acute Liver Failure Study Group (ALFSG), a clinical research network funded by the National Institutes of Diabetes, Digestive and Kidney Diseases (NIDDK). Subjects participating in the clinical registry of the ALFSG will be approached for enrollment. These patients all have the diagnosis of acute liver failure or acute liver injury from a variety of etiologies, including APAP. A single blood sample will be obtained and will be aliquoted for 1) testing by the dipstick and 2) testing by high performance liquid chromatography with electrochemical detection (HPLC-EC) analysis for APAP protein adducts. APAP levels will also be determined from the second aliquot of blood. In both Phase 1 and Phase 2, the dipsticks will be read manually and by dipstick readers by independent testers that are not directly involved in the clinical care of the patients. The results of the two dipstick readings will be recorded, will remain confidential and will not be used in the diagnosis or management of the patient. The results of the dipsticks and HPLC-EC assays will be compared to the final patient diagnoses.


Eligibility Criteria:
Part 1

Inclusion Criteria:

* Subject is 12-18 years of age.
* Subject has an APAP level ordered as part of clinical management.

Exclusion Criteria:

* Previous recent history of APAP overdose in the previous 30 days.

Part 2

Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject is enrolled in the ALFSG registry.
Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases---Shanghai Baoshan Study

Objective: Recruit 3 cohorts with 1000-1200 subjects each: people with normal glucose metabolism, impaired glucose regulation (IGR), and with Type 2 diabetes. To study the risk factors in development of type 2 diabetes.

Methods:

We aim to perform a two-step blood glucose survey in 2008-2009 in a population selected from a single urban community of Shanghai. The Institutional Review Board of the Rui-Jin Hospital approved the study protocol. Informed consent will be obtained from each participant.

1. In the first step, we first invited all registered permanent residents aged 40 or above by local poster advertisement and by mail to participate in a screening examination, during which we collected information on lifestyle, medical history and the use of medications using a questionnaire, and performed anthropometrical measurements and fasting glucose measurement. The first step of diabetes screening finished in June, 2008.
2. In the second step, after exclusion of subjects with self-reported diabetes, we classified the screened subjects into 3 groups according to their fasting plasma glucose concentration of 7.0 mmol/L or above, 5.0 to 6.9 mmol/L or below 5.0 mmol/L. We selected randomly a sample from these 3 subgroups for further investigation including a 75-g oral glucose tolerance test (OGTT) and blood and urine sampling and other vascular functional measurements. Our selection was based on a ratio of 1:1.2:1.44, because of the concern that by knowing the results of fasting plasma glucose test, subjects with lower glucose levels might have a lower participation rate than those with higher glucose concentrations. Nevertheless, this ratio was arbitrarily chosen. Finally, 1000 Type 2 diabetic patients, 1200 subjects with IGR and 1440 subjects with normal glucose metabolism were selected as target population of this study by random sampling for further blood and urine sampling.
3. Biomarkers and genetic risk factors will be evaluated in the study subjects.

Eligibility Criteria:
Inclusion Criteria:

* aged above 40 years

Exclusion Criteria:
A Study for Moderate Osteoarthritis of the Knee

This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.

Primary efficacy variable:

Number of patients showing 20% reduction from baseline in the WOMAC - pain subscale

Secondary efficacy variables:

* Number of patients showing a 50% reduction from baseline in the WOMAC - pain subscale
* Number of patients showing a 20% reduction from baseline in VAS-pain
* Number of patients showing a 50% reduction from baseline in VAS- pain
* Mean change (percentage reduction) in WOMAC scores for pain, stiffness and physical function from baseline, as compared to placebo
* Mean change (percentage reduction) in VAS - pain, as assessed at clinic visits and by daily records in patient diary (First two weeks only)
* Consumption of rescue medication
* Investigator's Global assessment of efficacy
* Subject's global assessment of efficacy

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male or female patients aged 30-65 years, and diagnosed of OA of the knee according to the ACR clinical and radiographic criteria
* ARA functional class II or III
* Kellgren Lawrence radiological severity of Grade II, Grade III OA knee
* Maximal OA pain on movement, as measured on a 0-100 Visual analog scale (VAS) should be more than 40 and less than 80 in the previous 24 hrs at screening and baseline visits

Exclusion Criteria:

* Conditions that can mimic OA knee pain, E.g. rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease
* BMI \>35 kg/m2
* Indication of surgery for OA knee
* Arthroscopy of either knee in the past year
* Use of analgesics or any other symptom-relieving medication within 7 days of screening
* Use of systemic steroids or herbal medication for OA within 4 weeks of screening
* Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months
* Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months
* History of osteoporotic/ osteoarthritic fractures within the past 6 months
* Pregnant or lactating women or women with inadequate contraceptive measures
* Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction)
* Presence of any clinically significant laboratory anomaly
* Known cases of AIDS (HIV positive)
* History of Coronary Angioplasty/CABG within the past 2 years
* Moderate to severe peripheral neuropathy or other neurological disorders
* Alcohol abuse, medication or drug dependence
* Concurrent or previous participation in a clinical study within previous 6 weeks
Premature Family Music Therapy Intervention (PFMI)

The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte". In NICU an integrated psychological and music therapeutic protocol has been structured. The protocol aims to limit or overcome long-term developmental morbidities, promote parenting and attachment bond in preterm infants. Protocol is named "Premature family music therapy intervention (PFMI): an Italian protocol to support parenting, attachment bond and preterm development". The methodologies will provide early intervention from the first days of hospitalization in NICU and use music therapy sessions "active" (chant parental, live music and lullaby) and "receptive" (listening to recorded tracks). Such therapy becomes a support for the born prematurely and her parents during hospitalization and after discharge. The music therapy accompanies the newborn and his parents during the hospitalization and focuses its attention on the emotional-relational care, according to the different needs of babies and parents.

This protocol it is a Family Centered Care Music Therapy Intervention.

All infants will be enrolled when in stable clinical condition within two weeks after birth. Therapy sessions will take place minimum three times per week on three different days of the week directly at the unit during the entire hospitalization until discharge. After discharge music therapy treatment will be performed once a week until twelve months of corrected age.

The infant's wellbeing and relaxation during each session of music therapy will be measured using the following parameters:

HRV (Heart Rate Variability) analysis Oxygen's saturation Stress level of the child

Infants will be followed till 12 months of corrected age. Investigators will assess:

Neuro-behavioral and neurological development of the child Stress level of the parents

Eligibility Criteria:
Inclusion Criteria, Preterm infants born, will be eligible for the study, if they will be:

1. Born between 22+6- and 32-weeks postmenstrual age
2. Weight less than 1500 g
3. Free from major congenital defects
4. Free from cerebral and/or intraventricular hemorrhage
5. Singleton or twin gestation
6. No sensorineural hearing loss (at discharge, passed bilateral hearing screening)
7. Free from Necrotizing enterocolitis
8. Free from severe retinopathy
9. No asphyxiated

11. No terms of surgical relevance 12. Born from HIV negative and drug free mothers

Exclusion Criteria, we will exclude infants whose mothers will be:

1. Affected by drug dependence
2. Affected by psychosis or other severe mental health problems
3. Unable to adequately speak/understand Italian language
4. Younger than 18 years of age
5. Physically unable to participate
De-Implementation of Low-value Testing in Patients Undergoing Low-Risk Surgery

This trial aims to evaluate the effectiveness of a multi-level, multi-component de-implementation strategy to reduce unnecessary preoperative testing. Sixteen Michigan Value Collaborative (MVC)/Michigan Surgical Quality Collaborative (MSQC) sites in Michigan will implement several tools that have been proven to reduce unnecessary testing at a single site, including clinician education, a decision aid, audit and feedback on performance, and a pay-for-performance incentive. The researchers believe that, through the use of these strategies, there will be a significant reduction in unnecessary preoperative testing during the intervention.


Eligibility Criteria:
Site

Inclusion Criteria:

* Over 30% of testing rates on at least one of the three index procedures (breast lumpectomy, laparoscopic cholecystectomy, and inguinal hernia repair)

Exclusion Criteria:

* none

Surgical participants must be over 18 years old.
Cortical Biomarkers of Hand Function and Recovery After Injury

This is a pilot study to collect data to support a VA grant submission to study fMRI and neurophysiological predictors of hand function and recovery during a robotic intervention in people with hand impairments due to stroke or spinal cord injury.

The loss of arm and hand function after cervical spinal cord injury (SCI) limits independence and increases the cost of care. As a result, Veterans with tetraplegia prioritize restoration of hand and arm function over all other rehabilitation goals. Similar to SCI, stroke of supraspinal areas involved in motor control results in acute movement deficits in more than 85% of survivors. Despite advances in treatment and rehabilitation, 50% of stroke survivors have persistent hand impairment. The loss of hand function and dexterity limits the ability to perform many activities of daily living, and thus limits independence. Since motor deficits are often permanent after SCI and stroke, new strategies are needed to restore dexterous hand function.

Advances in functional imaging have enabled the measurement of finger-related activation patterns in somatosensory cortex, but little is known about how these representational patterns are impacted when hand function is lost. Prior studies of gross movements have reported reorganization of cortical activity after injury. The investigators aim to improve dexterous hand function by increasing our understanding of finger-related cortical reorganization after lesions to the spinal or supraspinal structures. This understanding could allow discrimination between adaptive and maladaptive patterns underlying hand function and guide restorative therapies. Additionally, imaging biomarkers of injury often track with functional recovery.

The aim is to improve dexterous hand function by increasing our understanding of finger-related cortical reorganization after lesions to the spinal or supraspinal structures. This understanding could allow discrimination between adaptive and maladaptive patterns underlying hand function and guide restorative therapies. Additionally, imaging biomarkers of injury often track with functional recovery.

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected to normal vision
* Hand impairment due to spinal cord injury or stroke
* Weakness of fingers
* One year after stroke or spinal cord injury
* Some proprioception (can feel when finger is moved, without seeing)
* Minimal spasticity

Exclusion Criteria:

* Implanted metal with is unsafe for MRI
* Pregnant or expecting to become pregnant
* History of hand surgery which is under evaluation
* Cognitive or language issues that would interfere with following directions
* Other neurological disorder that would affect movement
* History of seizure or epilepsy
* Body weight \> 300 pounds