cyrilzakka/clinical-trials huggingface dataset:
Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)

To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT).

This study was conducted in two phases. In the first phase, the content development and validation phase, the key elements of robotic thyroidectomy with central neck dissection were broken down into 9 key steps for assessing the technical skills required to complete the procedure: creating the surgical area, exposing the thyroid gland, dissecting the upper pole of the thyroid gland with preservation of the superior laryngeal nerve (SLN), identifying and protecting the upper pole of the parathyroid glands, protecting the retractor laryngeal nerve (RLN), identifying and protecting the lower pole of the parathyroid glands, removing the thyroid, dissection of the central neck region and hemostasis.

The Delphi method was used for content validation of the 9 key steps. Each item was described using a Likert scale: 1 for worst and 5 for best. Experts were invited to evaluate each of the 9 key steps in terms of the description of the items and the agreement of the items with the assigned scores. Based on the Delphi method, the opinions of the experts were collected and consensus on the entry was indicated by determining that a content validity index (CVI) \> 0.75 (CVI measure: the proportion of experts who scored each entry 4 or 5. Consensus is considered to have been reached when the CVI reaches 0.75. For entries where consensus was not reached entries were revised to reflect any changes suggested by the expert group and the revised scoring system was recirculated for reassessment. This process is repeated until all entries have reached consensus.

In the second phase of the study, the structural validation phase, two consecutive 50 robotic by the same operator after a learning curve were scored. The aim was to analyze whether the scoring system developed in the first phase could assess operator progress and steps for improvement. In addition, the time taken to complete the procedure was recorded and compared. It was also analyzed whether there were any differences in the baseline (tumor size, location, age, gender, etc.) of the patients in the two groups (1st 50 cases and 2nd 50 cases).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
* Clinical diagnosis of benign thyroid nodules with a maximum diameter not exceeding 6 cm
* Participants with high cosmetic expectations
* Participants underwent robotic thyroidectomy without open conversion

Exclusion Criteria:

* Participants with history of neck surgery or radiation
* Participants with vocal fold fixation by preoperative fibrolaryngoscope
* Participants with preoperative examination suggestive of distant invasion
* Participants with fusion or fixed of lymph nodes in the neck
Comparing Consistency of QuantiFERON-TB Gold Plus and QuantiFERON-TB Gold for Latent Tuberculosis in Dialysis Population

In patients receiving long term dialysis, using new generation of QuantiFERON-TB Gold Plus can have less result variability in inter-experiment and serial follow up in comparing with QuantiFERON-TB Gold In-tube.

Tuberculosis (TB) remains one of the most important infectious diseases worldwide. According to the World Health Organization (WHO) estimates, there were 9 million new TB cases and 1.5 million related deaths in 2013. Future control strategies include early treatment for preventing transmission and treatment of latent TB infection (LTBI) for reducing reactivation. Patients with renal failure undergoing dialysis have increased risk of TB due to attenuated cellular immunity. For instance, their risk of developing active TB in the dialysis population is 7.8-25 times higher than that of the general population. However, TB diagnosis is usually delayed because of frequent extra-pulmonary manifestations. Thus, LTBI detection in this specific group is important.

Positive results of interferon-gamma release assays (IGRAs) and the exclusion of active TB are the current diagnostic bases of LTBI, which is a precursor of tuberculosis reactivation. However, recent reports show a high negative reversion rate of quantiFERON Gold In-tube (QFT-GIT), a kind of IGRA, in cohorts of health care workers (33% after 18 weeks) close TB contacts (35% after six months), and patients receiving long-term dialysis (46% after six months). This phenomenon questions the clinical significance of a single positive IGRA result. Increasing the IGRA threshold or doing serial follow-up to improve specificity have both been suggested but there is no comparison by the risk of TB development.

Therefore, increasing the accuracy and stability and then improving the rate of negative conversion from positive IGRA results are very important. Currently, new generation of QuantiFERON-TB Gold Plus includes two tubes for CD4 and CD8 T cells response, which can indicate TB immune response more specifically. The investigators applied this project to compare the performance of diagnosing LTBI by QuantiFERON-TB Gold Plus in comparing QuantiFERON-TB Gold In-tube.

Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 20 years
* Receiving long term dialysis

Exclusion Criteria:

* Having tuberculosis previously
Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma

This study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. The primary objective of this study is to assess duration of treatment in Turkish renal cell carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.


Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed as metastatic renal cell carcinoma
* Previous cytokine therapy
* To sign informed consent form (ICF)

Exclusion Criteria:

* Patients not willing to sign informed consent form or who withdraw their consent
BNT001 Digital Therapeutic Feasibility Pilot Study

This single arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application. BNT001 delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.

This pilot will study specific implementation barriers and facilitators, procedures that are necessary to ensure adherence to utilization of the digital program, as well as any potential safety issues associated with recruiting and offering an intervention to cancer patients with moderate anxiety or mild depressive symptoms. Data relating to patient experience, adherence, satisfaction and pre-post intervention outcomes will also be tracked.

The study will run in two distinct phases to first assess the process of clinical implementation by prescribing oncology clinicians, and in a second more expanded phase, further assess the clinical implementation and impact on enrolled patients.

Study Phase 1: We aim to identify promoters and barriers to the clinical implementation of BNT001, a software application that delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.

Study Phase 2: We aim to further identify promoters and barriers to provider clinical implementation of BNT001, assess patient acceptability and feasibility including patient adherence to BNT's 10-sessions, and obtain preliminary data on BNT001's impact on cancer-related distress.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis or history of invasive cancer (excluding non-melanoma skin cancer).
* Patients showing mild to moderate anxiety or depression on the Veteran System Assessment Screen (VSAS), with anxiety or depression scored as 1-6 on a 0-10 scale.
* Fluent in English.
* Has access to iOS or Android smartphone, or tablet and capable of receiving text messages.
* Has an e-mail address.

Exclusion Criteria:

* Endorses thoughts of self-harm, history of suicidality.
* Currently participating in investigative behavioral intervention trial for treatment of anxiety or depression.
* Participant is unable to complete training, has cognitive deficits, major psychiatric conditions, psycho-social conditions; lack of access to reliable internet and accessible device; other social conditions that would interfere with adherence to self directed care, such that in investigator's opinion the participant would be unable to complete the study.
* Recently completed use of Blue Note Therapeutics COVID Cancer Care Program or other Blue Note Therapeutics sponsored study.
Conditioned Pain Modulation in Chronic Neck Pain Patients

The aim of this study was to evaluate changes in local and segmental hypersensitivity and endogenous pain inhibition in people with chronic nonspecific neck pain.

Quantitative sensory testing is widely used in human research to investigate the state of the peripheral and central nervous system contributions in pain processing. It is a valuable tool to help identify central sensitization and may be important in the treatment of chronic neck pain. This study is a cross-sectional study. Two groups including chronic neck pain group and healthy volunteers group will be arranged in this study. The healthy subjects will be matched for sex and age in relation to the neck pain group. The pressure pain threshold (PPT) will be measured at the neck muscle in both groups. The cold pressor test will be used in both groups to activate conditioned pain modulation.

Eligibility Criteria:
1. Chronic neck pain subjects

   Inclusion criteria:
   * Age 21-80 years old.
   * People must have experienced neck pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.

   Exclusion Criteria:
   * Age under 21 or over 80.
   * Patients were excluded if they had taken pain medications on the day of the assessment or if they had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, nerve root compromise confirmed by clinical neurological tests or severe cardiorespiratory diseases.
   * Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded.
2. Healthy volunteers

Inclusion criteria:

* Age 21-80 years old.
* These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.

Exclusion Criteria:

* Age below 21 or over 80 years old.
* These participants have presented episodes of low back pain for more than 7 days in the last 12 months.
Caribbean and South America Team-based Strategy to Control Hypertension

The CATCH cluster randomized trial will test the implementation and effectiveness outcomes of implementing and scaling up a team-based care strategy for blood pressure control in Colombia and Jamaica.

The CATCH Study includes a two-year UG3 Planning Phase and a four-year UH3 Implementation Phase. In the UH3 Implementation Phase, we will first conduct a cluster randomized implementation trial to test the effectiveness and implementation of a team-based care strategy for hypertension control among patients with hypertension in 40 clinics from Colombia and Jamaica (20 in each country). Twenty clinics will be randomized to the team-based care intervention and 20 to provider training intervention. A total of 1,680 patients (42 per clinic) with uncontrolled hypertension will be recruited into the study and followed for 18 months for effectiveness and implementation outcomes. A post-intervention study visit will take place 6 months after the end of the 18-month intervention to evaluate the sustainability of the implementation strategies. We will subsequently conduct a pre- and post- scale-up comparison study to implement the team-based care strategy in all remaining public primary care clinics that provide chronic disease management in Jamaica and primary care clinics in the seven participating departments in Colombia. A pre- and post- scale-up comparison design will be used to assess barriers and implementation outcomes before and 12 months after the scale-up intervention at the clinic, primary care physician, nurse/pharmacist, and community health worker (CHW) levels.

Eligibility Criteria:
Inclusion criteria for clinics:

* Serving \>300 hypertensive patients during the previous year
* Clinic visits and BP medications are free of charge to patients
* Not sharing physicians, nurses, pharmacists, or community health workers (CHWs) with other clinics

Inclusion criteria for participants:

* Men or women aged ≥ 21 years who receive primary care from participating clinics
* Average untreated BP ≥140/90 mm Hg among individuals without a history of clinical cardiovascular disease (CVD), chronic kidney disease (CKD), or diabetes; average untreated BP ≥130/80 mm Hg among individuals aged ≥65 years or those with clinical CVD, CKD, or diabetes; or average treated BP ≥130/80 mm Hg from six BP readings at two screening visits
* Not pregnant or planning to become pregnant in the next 18 months
* Able and willing to give informed consent
* No plans to change primary care clinic in the next 18 months
* Not an immediate family member of staff at the primary care clinic
Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer

The purpose of this study is to determine whether Low-frequency Rotating Magnetic Therapy System is effective and safe in the treatment of advanced lung cancer.

The purpose of this study is to assess the efficacy and safety of the Low-frequency Rotating Magnetic Therapy System(with systemic anti-tumor therapy) compared to systemic anti-tumor therapy in patients suffering from advanced lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent
* Male or female aged 18 years and older
* Histologic diagnosis of non-small cell lung cancer (unable to receive surgery) or small cell lung cancer (limited stage or extensive stage)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3- going to receive systemic anti-tumor therapy
* Measurable disease based on RECIST 1.1
* Adequate hematologic and organ function

Exclusion Criteria:

* Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device
* Unable to lie in bed
* With any metal implants in body
* Human immunodeficiency virus (HIV)
* Malignancies other than lung cancer within 5 years prior to randomization
* History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial or interfere with the subject's participation for the full duration of the trial
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
Natural History of Pearson Syndrome

The purpose of this 3-year, multi-site, non-randomized, prospective, observational study is to characterize the natural history of Pearson Syndrome. The Syndrome is a rare mitochondrial disorder due to a large-scale mtDNA deletion. Children typically present in their 1st two years of life (most in infancy) with anemia and/or pancreatitis. Most individuals with Pearson Syndrome die in childhood. Those who survive evolve to Kearns-Sayre Syndrome/Chronic Progressive External Ophthalmoplegia (KSS/CPEO) although accurate survival estimates are not yet known.

All patients with confirmed Pearson Syndrome who satisfy the inclusion/exclusion criteria will be offered enrollment into this study. Patients followed at participating NAMDC clinical sites will be enrolled at those sites. Patients who are not followed at participating NAMDC clinical sites and wish to participate may contact one of the member sites directly or their local doctor may direct them to one of the member sites. Both male and female patients from all racial and ethnic backgrounds who satisfy the inclusion and exclusion criteria will be encouraged to participate. Children and adults will be eligible to be enrolled, but we expect the patient population to be mostly children.

Each patient with Pearson Syndrome who enrolls in the NAMDC Clinical Registry will be encouraged to participate in this study. Each patient enrolling in this study will be required to enroll in the NAMDC Clinical Registry either prior to or upon enrolling in this study. Demographic, medical history, biochemical, histological, genetic, and other clinical data from the registry will be incorporated into this study.

Every effort will be made to minimize the inconvenience to patients of participating in this study. The study-related activities at each patient visit will be kept to a maximum of one hour, and will, whenever possible, be scheduled to coincide with the patient's regular follow-up with his or her treating physician. This study is observational and has no associated medical procedures.

Eligibility Criteria:
Inclusion Criteria:

1. All individuals of any age with confirmed Pearson Syndrome are eligible to participate. Pearson Syndrome requires the presence of a large-scale mtDNA deletion along with sideroblastic anemia with or without pancreatic insufficiency.
2. All patients must agree to participate in the NAMDC Clinical Registry

Exclusion Criteria:

1. Patient does not fulfill criteria for Pearson Syndrome
2. Not willing to participate in the NAMDC clinical Registry
Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.

The purpose of this study is to evaluate salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to Stevens-Johnson Syndrome (SJS).

This study was performed to evaluate the use of salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to SJS. Labial mucous membrane and salivary gland transplantation showed to be a good option in the treatment of severe symblepharon and dry eye secondary to SJS. labial mucous membrane, salivary glands, symblepharon, entropion, transplantation, graft.

Eligibility Criteria:
Inclusion Criteria:

* Only patients with poor visual acuity, less or equal to 20/200, and Schirmer I test equal to zero.
* Eyes with symblepharon or ankyloblepharon that did not allow the placement of a Schirmer test strip will be consider not measurable.

Exclusion Criteria:

* Active infection and corneal melting or perforation.
Effects of Pilates Exercises and Neural Dynamic Mobilization in Sciatica Patients

The main purpose of the study is to find the effects of Pilates exercises and neural mobilization techniques on pain, flexibility and quality of life in sciatica patients. It will be a randomized controlled trial in which participants selected through non probability convenience sampling, to evaluate the effect of 6-week Pilates exercises versus neural dynamic mobilization techniques on pain, flexibility and quality of life in sciatica patients. Patients aged range from 18 to 65 years. The data will be collected from Service Hospital Lahore. Patients will have diagnosed with sciatica low back pain radiating down hip to knee, numbness, paresthesia and with positive SLR will include in this study whereas patients with considerable musculoskeletal deformity, previous hip, knee and ankle surgery and foot ulceration will be excluded from study .The participants will be randomly allocated to one of the two groups. Group A will perform Pilates mats exercises 30 minutes, two times a week and the Group B will perform neural dynamic mobilization for 15 minutes, two times a week, for 6-weeks respectively. Pain will be assessed by using BPFS, flexibility with Canadian sit to reach test and QOL with SF-36 questionnaire. SPSS software will be used for data entry and analysis.


Eligibility Criteria:
Inclusion Criteria:

* o Participants age ranged from 18 to 65 years old

  * Both genders.
  * History of nonspecific low back
  * lower extremity symptoms such as tingling, dull aches or burning sensation.

Exclusion Criteria:

* o Significant musculoskeletal deformity such as fracture, amputation.

  * Prior history of knee or back surgery
  * Lower extremity arthritis that limits standing and any inflammatory disease
  * History of cardiovascular issues such as angina, MI
  * Symptomatic postural hypotension
  * Foot ulceration.
  * Skin problems such as rashes etc.
Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis

This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas
* Overall disease severity is at least 3 (moderate)

Exclusion Criteria:

* Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment
* Subjects whose psoriasis involves only the scalp, face or groin
* Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
Microbial Community Composition and Metabolism in Cystic Fibrosis

Scientist have begun to realize that many types of bacteria often live together as a complex community, and the investigators wish to apply that idea to the bacteria in the respiratory system of people with Cystic Fibrosis (CF). It is possible that the survival of the many millions of bacteria in the CF lung depends on the production of special chemicals that might be made only by very few types of bacteria. If that is true, medicines that interfere with those chemicals could treat the lung infections that cause trouble for nearly all people with CF. The investigators wish to study the production of several potentially critical chemicals by the respiratory bacteria and to examine the effect of those chemicals on the makeup of the entire community of bacteria. To detect all the bacteria in that community, the investigators will use new methods that use bacterial genetic information and can detect hundreds of different types of bacteria in respiratory samples of individual CF patients.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of Cystic Fibrosis
* 2 to 55 years of age

Exclusion Criteria:

* None