cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Acupuncture for Phonotraumatic Injuries

The purpose of this study is to investigate the efficacy of acupuncture for the treatment of phonotraumatic lesions of the vocal folds, using the International Classification of Functioning Disability and Health (World Health Organization, 2001) as the conceptual framework to guide the selection of outcome measures.

The experimental hypothesis for this study is that needling at the designated treatment acupoints will bring about greater improvement in structural and functional impairment in the vocal folds and its sequelae, as compared to placebo treatment. However, it is further hypothesized that treatment benefits from acupuncture will be outweighed by continued phonotrauma following termination of treatment, and thus will not be maintained at long-term follow-up. Further, it is expected that voice-related quality-of-life improvements may be equal for genuine acupuncture as compared to placebo. Finally, it is hypothesized that the acupuncture protocol should have comparable effects for male and female subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Otolaryngological diagnosis within the preceding 15 days of swelling or thickening of at least one vocal fold, or nodules, fibrous mass, cyst, polyp, or chronic (non-infectious) laryngitis, which by history are traceable to phonotrauma and by history appear stable or worsening;
2. age 20-55 yr

Exclusion Criteria:

1. no prior voice therapy;
2. no medication or therapy that may affect voice during the period of participation;
3. no acupuncture treatment for any condition within the preceding 10 year;
4. no diagnosed or suspected neurological conditions, hearing loss (i.e. hearing threshold of the better ear not exceeding 35dB HL at 250 Hz, 500 Hz, 1000 Hz, 4000 Hz and 8000 Hz), history of asthma, and no upper respiratory infection at the time of recruitment.
Free Samples for Health

The Free Samples for Health (FreSH) study tests whether providing free samples of stop smoking medicine called nicotine replacement therapy at dental visits results in a greater number of people quitting smoking than providing a gift of equal value (an electric toothbrush).


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* smokes at least 1 combustible cigarette per day on at least 25 days of the month

Exclusion Criteria:

* does not own a smartphone with internet access
* myocardial infarction or stroke in the past 3 months
* pregnant or breastfeeding
* use of tobacco cessation medication in the past week
Diagnostic and Prognostic Biomarkers in Parkinson Disease

The overall goal of PROBE is to evaluate the feasibility and potential utility of three markers (alpha-synuclein, transcriptomic profiles and olfactory function) to determine the risk or prognosis of PD.

PROBE will test three biomarkers in PD subjects and controls to determine their feasibility and potential utility as markers of risk and prognosis for PD. This is a case control study, in which PD subjects will be compared to neurologically healthy controls and disease controls (MSA and PSP). The blood biomarker samples will be drawn once to evaluate blood alpha-synuclein levels as well as collection of lymphocyte mass for array analysis. Olfaction will be measured using the UPSIT for all subjects. The UPSIT will be conducted as part of PostCEPT for PD subjects and will only be repeated in this study for PD subjects in not done within 6 months. Control subjects may also choose to submit a blood specimen for processing and storage at the Coriell Institute for Medical Research, a research resource supported by the NINDS Human Genetics Resource Center.

Follow-up of the PD population over a 3-year period will allow us to evaluate the prognosis for important motor aspects of PD that will occur frequently in this cohort. These complications of PD include motor complications, postural instability, and non-motor impairment such as cognitive decline.

Healthy and disease control subjects may give permission at the Baseline visit to be contacted and followed in the previously established PSG FOUND study using mail and telephone contact to assess clinical status. Participation in the FOUND study provides another mechanism to maintain contact with subjects and collect supplemental data beyond that collected at the PROBE Baseline visit.

Eligibility Criteria:
Parkinson Disease Inclusion Criteria:

* Subject is participating in PostCEPT and meets UK brain bank criteria for PD
* Willing and able to provide informed consent

Healthy Control Inclusion Criteria:

* Spouse or non blood relative of the PD subject
* No known current diagnosis or history of a neurological disease
* MMSE score \>27
* Age \>45
* Willing and able to provide informed consent

Parkinsonism/Disease Control Inclusion Criteria (MSA and PSP)

* A diagnosis of Probable MSA based on Consensus Criteria OR Probable PSP based on NINDS-PSP Criteria
* Willing and able to provide informed consent

Exclusion Criteria for All Groups:

* Current use (within 7 days prior to Baseline Visit) of anticoagulants (e.g., warfarin or heparin)
* Known bleeding disorder (acquired or inherited)
* Known blood disorder (e.g. leukemia) or a history of anemia with a documented hematocrit \<30
* Known pregnancy
* History of nasal trauma, sinusitis, or other nasal pathology that would interfere with smell testing
Correlation Between Cyriax's Functional Examination and Ultrasound Examination in Patients With Shoulder Pain

Shoulder problems cause substantial disability in daily living, work, leisure activity, and exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly predictive of impaired health-related quality of life.

Many tests were used for physical examination of the shoulder. The reliability and validity of the tests have been studied before. However, a systemic review concluded that there was conflicting evidence in reliability of each or combined tests. Functional examination of the shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It includes three arm elevation, three tests for glenohumeral joints, and six resisted tests.

As far as the investigators know, correlation of Cyriax functional examination with the ultrasonographic findings has never been reported before. Therefore, the aim of this study is to compare the clinical diagnosis by Cyriax's functional examination with ultrasound findings in patients with shoulder pain.

There are two groups with fifty patients in each group. First group is patients who have unilateral or bilateral shoulder pain from the outpatient clinic of Department of Physical Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital. The other group is control group who has no shoulder problems. Both groups will receive Cyriax's functional examination of the shoulder after history taking, and will be examined by shoulder ultrasound in one week.

Eligibility Criteria:
Inclusion Criteria:

Study group:

1. patients with unilateral or bilateral shoulder pain with unknown causes;
2. age≥ 20 years old.

Control group:

1. patients without unilateral or bilateral shoulder pain;
2. age≥ 20 years old.

Exclusion Criteria:

1) chronic inflammatory joint disease, infections or tumors of the shoulder, previous fracture or surgery of shoulder, and referred pain from cervical origin or visceral organs.
Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C

The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C, Genotype 1
* HCV RNA ≥100,000 IU/mL at screening
* Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
* Naïve to prior anti-HCV therapy

Exclusion Criteria:

* Infected with HCV other than Genotype 1
* Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody at screening
* Evidence of liver disease other than HCV
* Active substance abuse
* Use of hematologic growth factors within 90 days prior to study randomization
* Evidence of history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma.

Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).

Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.

The process of performing an adrenalectomy for pheochromocytoma (PHEO) is difficult due to the significant risk of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).

Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral pheochromocytoma of any size, over 18 years old, both males and females

Exclusion Criteria:

* Patients undergoing initial open adrenalectomy, - Additional surgical interventions during total laparoscopic adrenalectomy, - Partial adrenalectomy,

Bilateral PHEOS. Hemorrhagic diathesis, Structural deformity Pregnancy,

- Prior unilateral abdominal surgery, data is absent. The preoperative diagnosis is ambiguous. Hereditary (PHEO), or recurrent PHEO
ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch and fiber optic sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Pass health screen
* 18 years or older

Exclusion Criteria:

* Fail health screen
Regulation of Retinal Bloodflow Pressure

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma. There is also evidence that autoregulation is impaired in patients with primary open angle glaucoma.

To gain more insight into these phenomena in humans is the primary goal of the present study.

The present study aims to investigate the pressure/flow relationship as a measure for retinal blood flow autoregulation during an experimental increase in intraocular pressure by the use of the suction cup technique. Retinal blood flow will be measured by Doppler OCT.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Non-smokers
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 1 Dpt.

Exclusion Criteria:- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

* Treatment in the previous 3 weeks with any drug (except contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnancy, planned pregnancy or lactating
Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis

Dose response curve to define the security and tolerable dose to be used for prevention and treatment of radiodermatitis in patients with breast or head and neck cancer.

The study is being conducted in Center for High Complexity Oncology (CACON) located at the University Hospital of Brasília (HUB). Has as its target population subjects diagnosed with breast and head and neck cancer undergoing radiotherapy. Three doses of urea cream are being tested. Participants are subjected to simple randomization technique, in which the members of the study are directly allocated in groups set forth, without any intermediate step. Patients are identified, go to a nursing consultation for general orientations about treatment. After the consultation, patients are invited to participate in the study. The patient should express its acceptance through the informed consent form. Data are being collected through interviews and medical records. Patients are being evaluated during three weeks, considering the toxicity of the intervention and the beginning of radiodermatitis. To evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS). For reliable assessment and record of the evolution throughout the treatment and study, patients will be photographed weekly (D0, D5, D10, D15). Will be photographed major regions subject to evaluation: frontal, right side profile and left side profile with Photographic camera Nikon P510. The data will be inserted into Statistical Package for Social Sciences (SPSS), version 18.0, for the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Being an adult, over the age of 18 years old
* Owning diagnosis of breast or head and neck cancer
* Being first referred to the radiotherapy protocol
* Have absence of radiodermatitis and integrates skin to start radiotherapy
* Not have presented anticipated reaction of hypersensitivity to chamomile or any plant of the family Asteraceae or Compositae or urea.
* Demonstrate conditions to continue the intervention in their home environment when needed.

Exclusion Criteria:

* Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.
Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients

The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes mellitus aged 18-69 years at inclusion into the study is to characterize in detail the clinical, metabolical and immunological phenotype and monitor the progression of the disease and to compare the phenotype to glucose tolerant humans of similar age, body mass and sex distribution.

In detail, the following questions will be answered:

1. Are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis?
2. Which factors modify the progression of the disease (Nutrition, subclinical inflammation, energy metabolism and physical activity)?
3. Can we identify subgroups at baseline with different progression of the disease? Patients are thoroughly examined at baseline and after 2, 5, and 10 years with annual telephone contacts in between.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diabetes mellitus according to ADA criteria
* Age 18-69
* Diabetes duration since diagnosis \< 12 months
* Control cohort: proven normal glucose tolerance according to ADA criteria

Exclusion Criteria:

* Diabetes mellitus category 3 B-H (ADA criteria)
* Pregnancy
* Severe renal, liver or heart disease
* malignant cancer
* severe psychiatric illness or addiction
* participation in an intervention trial
Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update

The aim of this observational clinical trial is to obtain data on the safety, efficacy and satisfaction of the Tandem T:Slim X:2 Pump System in patients with type 1 diabetes.

This is a non-randomized, non-blinded, prospective, observational single-center study, enrolling 2x 25 subjects in two cohorts (25 subjects in SWITCH group and 25 subjects in START group) with diabetes mellitus for up to 12 weeks. The study will evaluate the effectiveness of the insulin therapy with the pump system Tandem t:slim X:2 with the special algorithm "Control IQ" in comparison to each other. The test system including the Control IQ software will provide an Hybrid-Closed loop - Modus, which can predict the future tissue glucose value and continuously adjust the insulin infusion according to need. The aim is to keep the glucose value permanently within the target range and to avoid hypoglycaemia or hyperglycaemia.

Group START starts from any other diabetes therapy (MDI, PLGM (=Predictive Low Glucose Suspend), SaP (=Sensor augmented Pump)) directly to T:Slim pump with control IQ; group SWITCH switches from former use of T:slim with Basal IQ.

The study includes two visits only (start and end). At the beginning all patients have to complete questionnaires, and the data of the glucose sensor are read out and the metric data are determined and laid down.

Depending on the previous form of therapy, the patients are assigned to the corresponding cohort. All participants and parents, regardless of which cohort, receive a technical briefing from the study team as well as training on how to use the new system or algorithm. Subsequently, the system will be applied in everyday life in the coming weeks. After 12 weeks (end of study), the insulin pump is read out and the questionnaire on satisfaction with the device is filled out again.

After the end of the study, the patients participate in standard medical care as before.

Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent
2. type 1 diabetes
3. Age \>6 years
4. at least 10 IE daily total Insulin dose and 25 kg Body weight
5. Group SWITCH: already user of t:slim X2 with Basal IQ
6. Group START: Granting of the insulin pump t:slim X2 and DexCom G6 by the health insurance

Exclusion Criteria:

1.Refusal of participation by the participant or a parent
Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient

The research team is creating a foundational infrastructure in order to develop a precision medicine approach for geriatric patients who require surgery with anesthesia. The team plans to build the first of its kind comprehensive database of demographic and risk factor questionnaire responses, biobanked blood specimens, intraoperative electroencephalography (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop appointment until a year later. This will be used to create a predictive model of periooperative neurocognitive disorders.


Eligibility Criteria:
Inclusion Criteria:

* At least 65 years old (inclusive)
* Non cardiac general elective surgery
* General anesthesia is expected for 2+ hours

Exclusion Criteria:

* Alzheimer's
* Dementia
* Parkinson's
* History of neurodegenerative diseases
* Medication for depression (ie. Benzodiazepines)
* Alcoholism
* Discretion of PI
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* refractory, relapsing or chronic idiopathic thrombocytopenic purpura;
* stable therapy during 3 weeks prior to study entry.

Exclusion Criteria:

* newly diagnosed ITP (\<6 weeks);
* prior treatment with MabThera;
* active bleeding requiring platelet transfusion within 7 days prior to entry into study.
Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock

Septic shock is the most severe form of a bacterial infection, affecting 24 million patients per year worldwide, with a high mortality (\> 30%).

Septic shock is defined by an acute circulatory failure, with low blood pressure and insufficient oxygen supply to organs. This circulatory failure is related to vascular damages, in which the endothelial vascular tissue is impaired by inflammatory mechanisms, with release of circulating endothelial cells in the blood.

Therefore, modulating inflammation on the vascular endothelial tissue could be a therapeutic strategy, and the investigators focus on the role of the type I interferons on the endothelial tissue because of the demonstrated role of type I interferons during septic shock.

Thus the investigators proceed to an observational study, in which the primary purpose will be to show a higher expression of type I interferon receptors on circulating endothelial cells in patients with septic shock compared to control subjects.

Concerning secondary purposes, the investigators will record mortality at d3, d7 and d28, perform assays about types I, II and III interferons in plasma, and test anti-interferon on endothelial cells ex vivo


Eligibility Criteria:
* For all subjects
* Age \> 18 years old
* For females: negative pregnancy test
* Subject covered by health insurance
* Written consent
* Patients with septic shock
* Patients must be in ICU
* Septic shock defined by the Sepsis-3 criteria \[1\]
* Inclusion within the 12 hours following the onset of norepinephrin
* Controls :
* Blood donors

Exclusion criteria:

* Moribund
* Age \< 18 years old
* Absence of written consent
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.

This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years;
* Intubated and mechanically ventilated ≤96 hours before enrollment；
* Expected to require continuous invasive ventilation and sedation ≥24 hours;
* Requirement for light to moderate sedation (a RASS score of -3 to 0).

Exclusion Criteria:

* Body mass index (BMI) \<18 or \>30 kg/m2;
* Acute severe neurological disorder and any other condition interfering with RASS assessment;
* Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
* Heart rate less than 50 beats/min;
* Second- or third-degree heart block in the absence of a pacemaker;
* Unstable angina;
* Acute myocardial infarction;
* Left ventricular ejection fraction less than 30%;
* Contraindicate or allergic to study drugs;
* Moribund state;
* Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
* Chronic kidney disease with glomerular filtration rate (GFR) \< 60 ml/min/1.73m2;
* Alcohol abuse;
* Myasthenia gravis;
* Pregnancy or lactation.