cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial Comparing Performance of Molecular Markers for Indeterminate Thyroid Nodules

The purpose of this study is to compare the performance of Afirma GSC and ThyroSeq v.3 in indeterminate thyroid nodules to determine which test can allow more patients to avoid unnecessary surgery and preserve quality of life. In the initial phase of this study, the performance of Afirma GEC and ThyroSeq v.2 were compared.

1. All patients undergoing thyroid FNA within the UCLA Health System will be randomized at the time of FNA to a single molecular test (GSC or ThyroSeq v.3). In the previous phase of the study, patients were randomized to the previous versions of a single molecular test (GEC or ThyroSeq v.2).
2. During the FNA, a sample will be collected for the molecular test.
3. If the cytology results are indeterminate (Bethesda categories 3 or 4), the molecular test will be reflexively sent off.
4. We will help patients with indeterminate thyroid nodules to establish care with an endocrinologist, if they do not already have one. The physicians will make treatment recommendations using best practices and incorporating the results of the molecular test. We anticipate that most patients with a positive molecular test will undergo surgery, while the majority with a negative test will be surveiled.
5. Patients who undergo surgery will have histopathologic evaluation of the thyroid, which will determine whether the index thyroid nodule was benign or malignant.
6. Patients who do not undergo surgery will have a followup ultrasound at 6 and 12 months, or sooner at the discretion of the treating physician.
7. We will assess thyroid-specific quality of life at baseline (following initial diagnosis of an indeterminate thyroid nodule) and during followup (at 6 and 12 months) using the short version of Thyroid-Related Patient-Reported Outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a thyroid nodule who have a thyroid biopsy performed at UCLA health will be eligible for the study and consented if they agree to participate.
* Patients who have an indeterminate FNA biopsy result (Bethesda category 3 or 4) will be enrolled in the study if they agree to participate.

Exclusion Criteria:

* Patients who do not have an indeterminate biopsy result (either patients who have a benign, insufficient, or malignant result).
A Study of Ketamine in Patients With Treatment-resistant Depression

The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).

This is a double-blind (patients and study personnel do not know the identity of the administered treatments), randomized (the drug is assigned by chance), placebo-controlled (placebo is a substance that appears identical to the treatment and has no active ingredients), parallel arm study (each group of patients will be treated at the same time). The study will consist of a screening phase of up to 4 weeks, a 4-week double-blind treatment phase (Day 1 to Day 29), and a 3-week post treatment (follow up) phase. In the double-blind phase, patients will receive over 4 weeks either intravenous (IV) infusions of placebo (2 or 3 times weekly) or IV infusions of ketamine (2 or 3 times weekly). The total study duration for each patient will be a maximum of 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Be medically stable on the basis of clinical laboratory tests performed at screening
* Meet diagnostic criteria for recurrent major depressive disorder (MDD), without psychotic features
* Have a history of inadequate response, ie treatment was not successful, to at least 1 antidepressant
* Have an Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) total score \>= 40 at screening and predose at Day 1
* Inpatient or agreed to be admitted to the clinic on each dosing day

Exclusion Criteria:

* Has uncontrolled hypertension
* Has a history of, or current signs and symptoms of diseases, infections or conditions that in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
* Has known allergies, hypersensitivity, or intolerance to ketamine or its excipients
* Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure

Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding.

Subjects will receive oral avatrombopag once daily for 5 days beginning on Day 1, followed by a wait period prior to the procedure, which will occur on Day 10 to 13. The Follow-up Period will include 2 visits; 7 days post-procedure and 30 days after last dose.

Eligibility Criteria:
Inclusion Criteria:

* Men and women greater than or equal to 18 years of age;
* A mean baseline platelet count between:

  * 50 × 10\^9/L and \<100 × 10\^9/L for non-chronic liver disease participants
  * 50 × 10\^9/L and \<75 × 10\^9/L for participants with chronic liver disease;
* Participant is scheduled to undergo operations to critical sites (eg, eye surgery, neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), or, in the opinion of the Investigator, would otherwise require a pre-operative platelet transfusion to prevent bleeding

Exclusion Criteria:

* Participant with a history of arterial or venous thrombosis within 6 months of baseline;
* Participant with known portal vein blood flow velocity rate \<10 cm/second or previous portal vein thrombosis within 6 months of baseline;
* Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Baseline Visit;
* Use of erythropoietin-stimulating agents;
* Participant has a known medical history of genetic prothrombotic syndromes; or
* Participant has abnormal hemoglobin levels or prothrombin time/international normalized ratio
Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.

* Prospective, parallel design
* Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = \>75% airway obstruction), upper respiratory tract infection or nasal discharge.
* Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam;
* Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
* Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered).
* Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation.

Eligibility Criteria:
Inclusion Criteria:

* healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments.

Exclusion Criteria:

* enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = \>75% airway obstruction), upper respiratory tract infection or nasal discharge.
Technology Assisted Rehabilitation for Upper Limb Function in Myotonic Dystrophy Type 1

Myotonic Dystrophy type 1 (DM1) is a genetic multisystem disease causing muscle weakness and myotonia. As a result, upper limb function might become impaired. There are little research regarding rehabilitation and exercise for upper limb function in DM1. It is known from research on lower limb function in DM1 and other muscular dystrophies, that there are possibilities to improve function also in these deteriorating diseases. In this single subject experimental design study, 6-10 adults with DM1, who are at an inpatient rehabilitation center, will get intensive, but personally adapted senso- and robot assisted rehabilitation for arm- and hand function with Tyromotion Amadeo and Armeo Senso. These devices have previously been used in rehabilitation research for other neurological conditions. The participants will be followed up, and evaluated at a weekly basis, using video consultations. Fine motor skill dexterity test (9HPT) and the Nut and Bolt test will be used, and active range of motion (ROM) and muscle strenght and movement of upper limb will be measured. Furthermore, patient reported outcome measures (PROMS) on hand impairment and myotonia will be used, all with purpose to evaluate upper limb function.


Eligibility Criteria:
Inclusion Criteria:

* Granted rehabilitation at Vikersund Rehabilitation center Genetical confirmed myotonic dystrophy diagnosis MIRS score between 2-5

Exclusion Criteria:

* MIRS score on 1 Reduced Cognitive function and unable to participate in technological rehabilitation and digital evaluation
Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects

The objective of this study is to investigate how quickly and to what extent the 14-Carbon labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is radioactive, this enables the compound to be traced in blood, urine and feces.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 to 50 years inclusive at screening
* Healthy as determined by the investigator on the basis of screening evaluations

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Sound and Vision: A Collaboration Between Service-users, Artists and the Public to Explore the Lived Experience of Hallucinations

Sound and Vision: A collaboration between service-users, artists and the public to explore the lived experience of hallucinations

Sound and Vision will pair local artists with patients who have had hallucinations to create art pieces that represent their hallucinatory experiences. Patients with diagnoses of schizophrenia and Parkinson's disease will be invited to take part in participating National Health Service (NHS) clinics, to capture and compare a wide range of hallucinatory experiences. Patients will meet with artists on several occasions who will then develop the piece, which may be a painting, drawing, or other media that the artist and service-user jointly select.

Completed artworks will be the centrepiece for an exhibition at United Kingdom (UK) science festivals and a digital (on-line) presentation. The exhibition will be accompanied by researchers explaining the brain science of hallucinations, recordings of patients and artists describing their experience with hallucinations and the process of developing the artworks, booklets cataloguing the exhibition, and art materials available for artistic expression of their own experiences. A digital compendium of the artworks and supporting material will be publicly available alongside the opportunity to complete an online survey exploring the themes of the artworks and collecting information on personal experiences. The objectives are to engage the public in an appreciation of the experience of hallucinations and their prevalence across many common mental health and neurodegenerative disorders, as well as an experience many people will share without ever being diagnosed. The exhibition will also encourage the public to share their own experiences through the online questionnaires creating a platform to begin to improve the understanding of the diversity of hallucination-like experiences in the general population.

Eligibility Criteria:
No particular inclusion or exclusion criteria
Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention

This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably alter biomarker expression, whether serum carotenoids levels are associated with biomarkers levels, and whether the alterations of biomarker expression may reflect the cancer risk as shown by cancer incidence at the end of the clinical trial.

Many epidemiological studies have shown that nutrients or elements from tomato or other plants, including lycopene and multi-carotenoids, may reduce the risk of prostate cancer, especially those of lethal cancer. Studies have also shown that multi-carotenoids may reduce serum PSA levels in prostate cancer patients. MCS is a patented, multi-carotenoids-rich, purely botanic agent. The investigators' previous Phase II and III clinical trials (US FDA and TFDA, 600 subjects, studies finished, data in analysis) have shown that there were no MCS-related serious adverse events (SAE). MCS may relieve urinary symptoms in men with BPH and PSA was reduced in men with elevated PSA. So, the investigators are initiating a large multi-center phase II randomized study (MCS-8, N=702) in Taiwan, to study if MCS can reduce the risk of prostate cancer. High risk patients will be assigned to take oral daily 30, 15, and 0 (placebo) mg of MCS (1:1:1). The investigators will compare the cumulative prostate cancer incidence among groups and the change from baseline in serum carotenoids levels.

(MCS-8-TWN-II Clinicaltrials.gov NCT02042807)

Eligibility Criteria:
Inclusion criteria:

1. Subject of MCS-8 study inclusion criteria of MCS-8 study

1. high-risk subjects of prostate cancer.
2. Male subject with age from 50 to 75 years old.
3. No active urinary tract infection (UTI) or bacterial prostatitis.
4. Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).

exclusion criteria of MCS-8 study

1. Subjects' elevated PSA is deemed by the investigators solely to inflammation or infection of the prostate.
2. Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
3. Subjects with a PSA \> 10.0 ng/ml.
4. Subjects with a history of prostate cancer.
5. Subjects are currently taking or planning to take oral bile acid sequestrants.
6. Subjects have malabsorption conditions.
7. Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
8. Subjects are considered ineligible for the study as judged by the investigator.
9. Other malignancies except non-melanoma skin cancer.

2. Subject is eligible for MCS-8 study but did not sign up for the MCS-8 study.

Exclusion criteria:

Subject is not able to understand and willing to comply with the study procedures and has not signed the informed consent form (ICF).

Note: (MCS-8-TWN-II Clinicaltrials.gov NCT02042807)
HXLPE Vs CPE Cups Under 50 Years

This randomized controlled trial evaluated the long-term wear of cemented highly cross-linked polyethylene (HXLPE) versus conventional polyethylene (CPE) acetabular cups in patients under 50 years undergoing primary total hip arthroplasty (THA).

All surgeries were performed at Radboud University Medical Center by three surgeons using a posterolateral approach. Acetabular components included either highly cross-linked polyethylene (HXLPE) cups (X3 RimFit) or conventional polyethylene (CPE) cups (Exeter Contemporary Flanged). Both were implanted with bone cement, and femoral components consisted of Exeter V40 stems with 28 mm cobalt-chromium heads. Impaction bone grafting (IBG) was routinely used, with mesh applied in cases of acetabular bone defects.

Radiographs were taken preoperatively and at 10-year follow-up using standardized protocols. Polyethylene wear was assessed with PolyWare software, creating 3D models from baseline and 10-year radiographs to calculate linear and volumetric wear. Cup inclination and osteolysis were evaluated in three acetabular zones (DeLee and Charnley classification).


Eligibility Criteria:
Inclusion Criteria:

* primary THA
* age under 50 years

Exclusion Criteria:

* THA due to an oncological condition
Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France

As mental health care shifted from state psychiatric hospitals to the community in France and western countries, the mental health system became inevitably involved in housing as it strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers found themselves unable to find stable living in the community and struggling with addictions, they became a significant subgroup within a larger homeless population, which has received increasing policy attention over the past three decades. There are two distinct service models for adults who have severe mental illness and are homeless: the residential continuum model and the Housing First model.


Eligibility Criteria:
Inclusion Criteria:

aged over 18;

* who are absolutely homeless or precariously housed. Absolutely homeless is defined as having had no fixed place to stay for at least the past seven nights with little likelihood of finding a place in the coming month. Precariously housed is defined as being housed a in single room occupancy, rooming house, or hotel/motel as a primary residence AND in the past year having experienced two or more episodes of being absolutely homeless OR one episode of being absolutely homeless that lasted for more than four weeks in the preceding 12 months.
* living with schizophrenia or bipolar disorder (diagnosis of DSM-IV);
* with a sufficient understanding of written and spoken French to be able to provide informed consent and to participate to face-to-face interviews;
* affiliated to a social protection;
* who have lived in the city targeted for at least 6 months and willing to stand in the city during the 2 next years;
* with a global score measured on Multnomah Community Ability Scale (MCAS) (scale \<=62 (high need criteria));
* hospitalized at least twice on the past 12 months OR held in prison on the past 24 months OR presenting substance or alcohol abuse or dependence (high need criteria).

Exclusion Criteria:

* being considered unable to provide informed consent;
* having dependent children;
* pregnancy;
* or a DSM-IV Axis I diagnosis other than schizophrenia or bipolar disorder
A Feasibility Study in Combat Athletes with Mild Traumatic Brain Injury

The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).


Eligibility Criteria:
Patients meeting the inclusion criteria will be based on the type of associated suspension; 30-day suspension (head injury without technical knockout or incapacitation), 60-day suspension (head injury with technical knockout or incapacitation), 90-day suspension (head injury with loss of consciousness). These suspension groups are not based on GCS; therefore, GCS is not part of the inclusion criteria. The suspension group injury severity would not include moderate to severe GCS \<13. This group will be divided into randomized groups, patients who will be treated with HBOT and patients who will receive the standard of care, which is rest.
A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.

This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.

This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged at least 18 years old
2. Patient undergoing routine flexible cystoscopy
3. No active urinary tract infection
4. Subject is willing and able to sign informed consent and HIPAA authorization.

Exclusion Criteria:

1. Known unpassable urethral stricture
2. Febrile patient with active urinary tract infection (UTI)
3. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
4. Subject with severe coagulopathy
5. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prior Therapy Favors Direct-acting Antiviral Treatment Efficacy

The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in Hepatitis C virus (HCV)-infected patients receiving direct-acting antiviral treatment

Presence of anti-E1E2 antibodies was previously associated with spontaneous cure of hepatitis C virus (HCV). The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in HCV-infected patients receiving direct-acting antiviral treatment

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* HCV patients treated with direct-acting antiviral treatment
* Patients with a prior treatment blood sample
* Patients with sustained virological response or virological relapse

Exclusion Criteria:

* HIV or hepatitis B virus (HBV) coinfection