cyrilzakka/clinical-trials huggingface dataset:
TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial;
* Age 18 \~ 75 years old, gender is not limited;
* Documented physician diagnosis of asthma at least 12 months prior to Visit 1;
* Subjects who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to Visit 1;
* There must be a record of receiving a stable total daily dose of ICS at least 3 months prior to visit 1;
* There must be a record of the use of other asthma control medications at a stable dose at least 3 months prior to visit 1; For subjects taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg every other day (or equivalent) and must be stable for at least 30 days prior to visit 1 and during treatment.
* Documented at least 2 asthma exacerbations in the 12 months prior to Visit 1 and no major asthma exacerbation events in the 1 month prior to signing informed.

Exclusion Criteria:

* Have a clinically significant lung disease other than asthma；
* Pre-existing autoimmune disease;
* A history of known or suspected immunosuppression, including a history of invasive opportunistic infections;
* Any disease that has not been determined to be stable by the investigator；
* Cancer history: Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ are eligible to be enrolled in this study if they had completed curative therapy for at least 12 months prior to visit 1. Patients with other malignancies who had completed curative treatment for at least 5 years prior to visit 1 could be enrolled in the study.
* Current smoker or smoking history ≥10 pack-years (former smokers with smoking history \<10 pack-years had quit smoking less than 6 months before interview 1);
* Other factors determined by the investigator that subjects were not suitable to participate in the study.
The Effect of Preoperative SGB on POAF After VATS

The aim of this study is to test if stellate ganglion block can decrease the incidence of atrial fibrillation after video-assisted thoracoscopic surgery and the way it works.

Postoperative atrial fibrillation (POAF) is a common complication after video-assisted thoracoscopic surgeries. It leads to early postoperative complications, prolonged ICU stay and hospital stay, increased hospital expense and medical system burden. POAF is hard to predict and difficult to treat. The potential mechanism of POAF is not fully understood. Since early 2020, covid-19 overwhelmed globally. Chest X-rays and CT scans prescribed enormously due to screening for covid-19 infection. Lung nodules are frequently discovered and the number of video-assisted thoracoscopic procedures is surged. Prevention and new targets of treatment of POAF need to be investigated urgently. This is a double blinded, randomized controlled trial, investigating the effect of autonomic nervous system modulation on POAF. In current study, patients with one or more POAF risks, who undergo video-assisted thoracoscopic lobectomy will be enrolled and randomized into two groups. Participants in the SGB group receive stellate ganglion blocks (SGB) preoperatively, while those in the control group receive sham blocks. All the patients receive standardized anesthesia and video-assisted thoracoscopic procedures. All of participants will be monitored with portable ECG monitoring for 48 hours to detect any POAF occurrence. Cytokines including IL-2, IL-6 and inflammatory bio-markers including C-reactive protein and white blood cell count are measured before surgery, 24h and 48h after surgery. The primary outcome is the occurrence of POAF and its duration. The sample size is calculated as 191 patients per group. The presumed result will be that SGB will lower the POAF incidence and shorten the duration after video-assisted thoracoscopic surgeries.

Eligibility Criteria:
Inclusion Criteria:

* 1.patients undergoing elective thoracoscopic lobectomy;
* 2.patients with one or more risk factors of POAF. According to literature, risks factors of POAF including male, aged over 65, obesity (BMI\>30kg/m2), cardiac co-morbidity ( hypertension, myocardial infarction, heart failure, arrhythmia, history of valve procedure), diabetes, chronic renal insufficiency (increased creatinine level), obstructive sleep apnea syndrome (diagnosed or STOP-BANG scores ≥3).

Exclusion Criteria:

* 1. patients with permanent atrial fibrillation, left ventricular or right ventricular pacemaker implantation or removal;
* 2. patients use antiarrhythmic drugs (except beta-blockers);
* 3.patients use immunosuppressive drugs preoperatively;
* 4.patients with active infection or sepsis;
* 5. patients with neurologic disorder;
* 6.patients with immune deficiency syndrome.
The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis

This study aims to measure the effectiveness of vitamins C and E on relieving RLS symptoms in end stage renal disease patients on HD

double-blind placebo-controlled trial of 12 weeks duration on end stage renal disease (ESRD) patients on HD with RLS.

All ESRD patients on HD will be screened clinically for RLS using the five diagnostic criteria of IRLSSG by trained physicians. then the Quastioniare will be filled and inclusion and exclusion criteria be checked sleep study must be done.

Each patient will then undergo a full sleep study using level 2 polysomnography at home. Periodic leg movements with sleep (PLMs) index and leg movements index (LM) before sleep onset will be recorded as well as other variables

Then Subjects will then be randomly assigned by blocked randomization into four groups, each group will include 40 patients. A. Group 1: Will receive vitamin C (200 mg) tablet and vitamin E (a-tocopherol) (400 mg) capsule every day for 12 weeks. B. Group 2: Will receive vitamin E (400 mg) capsule and placebo every day for 12 weeks.

C. Group 3: Will receive vitamin C (200 mg) tablet and placebo every day for 12 weeks. D. Group 4: Will receive two placebo every day for 12 weeks. Of note, the personal responsible for randomization will not be involved in the trial.

Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease patients on hemodialysis who met the five diagnostic criteria of RLS.

Exclusion Criteria:

* Secondary causes of RLS Medications (list included in section C below) iron deficiency or peripheral neuropathy

Presence of RLS-mimicking disorders:

1. Arthritis
2. Deep venous thrombosis
3. Varicose veins or venous insufficiency
4. Habitual foot tapping

Patients receiving medications that could trigger RLS:

1. Anticonvulsants, e.g., new use of anticonvulsant drugs within6 months of screening. A stable regimen of anticonvulsants was allowed.
2. Antipsychotics (haloperidol or phenothiazine derivatives)
3. Antidepressants (selective serotonin reuptake inhibitors or tricyclic antidepressants)
4. Antimanic (lithium)

Patients on medications or with conditions that may interfere with vitamin C \& E absorption:

1. Celiac disease
2. Crohn's disease
3. Chronic pancreatitis
4. Cystic fibrosis
5. Weight-reduction drugs
6. Chemotherapy and radiotherapy

Patients with contraindications for vitamin C \& E supplements:

1. Blood disorders, e.g., thalassemia, G6PD, sickle cell disease and hemochromatosis
2. Other conditions like diabetic patients, oxalate nephropathy, nephrolithiasis and vitamin E or C allergy
3. Unstable vital signs
4. Retinal eye disease
5. Cancers
6. Liver disease
7. Vitamin K deficiency

For women only:

1. Pregnancy (positive pregnancy test at screening)
2. Currently breastfeeding
3. Use of oral contraceptives or start of menopausal hormone therapy within 3 months of baseline

History of vitamin E or C intolerance
A Multicenter Prospective Study of "High Risk" Molecular Typing in Patients With Adult T Lymphoblastic Lymphoma

The purpose of this study is to determine the indicative value of "high risk" molecular typing in patients with adult T lymphoblastic lymphoma


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved T lymphoblastic lymphoma
* newly diagnosed patients

Exclusion Criteria:

* patients with biopsy samples unavailable
Hypertonic Saline Injection For Urinary Incontinence

The investigators aimed to evaluate the effectiveness and safety of periurethral hypertonic saline (10% NaCl) injection for the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI) in women.

This single-center prospective pre-post interventional study was conducted between January 2014 and April 2018 with 65 women (44 SUI, 21 MUI). Quality of life was evaluated with the Incontinence Quality of Life Scale (I-QoL) and the lower urinary tract symptoms of women were evaluated with the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS). Incontinence status was assessed via the Stamey Incontinence Grade scale. Patients with MUI also were evaluated using the Urinary Distress Inventory-6 (UDI-6). The need for additional treatment (re-injection, other surgical approaches, etc.) was recorded.

Participants were followed up to 24 months after intervention. All outcomes of interest and complications were evaluated/recorded at six preplanned visits (postoperative 1st, 3rd, 6th, 12th, 18th, 24th months).

Eligibility Criteria:
Inclusion Criteria:

The patients who described Stress Urinary Incontinence or Mixed Urinary Incontinence, those who had incontinence during the Valsalva maneuver, patients with positive Marshal-Marchetti test, and those with post-void residual urine volume ≤100 mL were included in the study.

Exclusion Criteria:

Temporary urinary incontinence, delirium, urinary tract infection, urethritis, pure urge incontinence, nocturnal enuresis, decreased bladder compliance and detrusor contraction in the urodynamic study, leakage of urine with low bladder pressure, psychiatric conditions (severe depression and anxiety), body mass index (BMI) \>35 kg/m2, and using drugs that may influence bladder storage or emptying
Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia

Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as "Senile Dementia," accounting for 60-80% of all dementia cases. Currently, there are approximately 10 million AD patients in China, with the number showing an increasing trend year by year, imposing a heavy economic and caregiving burden on families and society. Studies have shown that AD has a clinically silent period of 15 to 20 years (SCD\\MCI), where the risk of developing dementia is ten times higher than that of healthy elderly individuals. Nearly 50% of MCI patients progress to dementia within 5 years, and about 14.1% of SCD patients develop dementia within the same timeframe. Early detection, diagnosis, and intervention are currently the most effective strategies for preventing and treating AD. Therefore, this study aims to verify the intervention effect of integrated cognitive intervention in high-risk populations for senile dementia (SCD, MCI) based on the cognitive rehabilitation model through randomized controlled trials, and to analyze attrition rates, participation rates, etc., which have good research and application value.

Based on the cognitive rehabilitation model, this study aims to develop a digital multimodal cognitive intervention program, and conduct feasibility studies and randomized controlled trials. The intervention includes health knowledge education, exercise intervention, art intervention, and cognitive training, etc. The feasibility, effectiveness, and safety of this intervention approach will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* MCI (refer to Peterson's diagnostic criteria) or SCD (refer to the diagnostic framework proposed by Jak bondi and Jessen et al.);
* Able to communicate normally in Mandarin;
* Certain level of comprehension and judgment abilities, aware of the purpose of the survey and consents to participate.

Exclusion Criteria:

* Patients with dementia exhibiting abnormal mental behavior;
* Individuals with severe hearing or speech impairments;
* Those with serious physical illnesses who are unable to cooperate and complete the survey.
Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

A database analysis and review of histological slides (retrospective) and a patient questionnaire analysis (prospective) will be conducted in Bern (Switzerland) to evaluate the efficacy and safety of esophageal dilation and its effect on the underlying eosinophilic inflammation in patients with Eosinophilic Esophagitis. This trial is investigator driven.

Eosinophilic esophagitis (EE) is a chronic, increasingly recognized disease of the esophagus, clinico-pathologically characterized by a proton-pump-inhibitor resistant, dense esophageal eosinophilia in combination with esophagus-related symptoms. Patients suffer mainly from dysphagia, a feared long-term complication is the evolution of esophageal stenoses leading to food-bolus impaction that have to be removed endoscopically. Anti-inflammatory therapy with systemic or topical corticosteroids have shown to be efficacious in children as well as in adults. However, relapses occur in general soon after the cessation of this medication. In addition, several studies have demonstrated that in adults with active EE dilation is an alternative safe and efficacious therapeutic option. Surprisingly, the symptom-free period seems to be much longer after this procedure than after medical treatment. Today, the selection of these two procedures depends more on local practices than on evidence based data, because robust data are lacking. Furthermore, there are concerns regarding the risk of the dilation-procedure (possible esophageal perforations and major bleeding). Furthermore, it has not yet been assessed if dilation changes the underlying eosinophilic inflammation. If not, investigations should be performed to evaluate if long-term anti-eosinophilic therapy is able to change the natural course of the disease and reduce the stricturing complications.

Eligibility Criteria:
Inclusion criteria for retrospective Database analysis:

* Adult patients with - according to the database inclusion criteria - confirmed active EE, having

  1. Pre-dilational upper endoscopy (EGD) including histology and
  2. Dilation and
  3. Post-dilational EGD/Histo
* Definitions: Active EE is defined as

  1. Symptoms of dysphagia on almost each intake of solid food when off anti-inflammatory therapy or dietary restriction;
  2. Presence of an eosinophilic tissue infiltration with a peak cell density of \>24 eosinophils per hpf x 400 on histology of esophageal biopsies.
* Inclusion criteria for additional, prospective, comprehensive histologic and immunologic
* Work-Up: "Comparable" time frame between baseline and post-dilational biopsy sampling

Exclusion criteria:

* Therapy with anti-eosinophilic medications 12 weeks prior to pre-dilational EGD and dilation respectively and between dilation and post-dilational EGD/Histo.
To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.

this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Male and Females aged ≥ 40 and ≤ 65 years of age.
* Participants with primary complaints of lower limb pain.
* History of Diabetes mellitus for more than one year.
* Participants with HbA1c ≥ 7.1 and ≤ 9.5%

Exclusion Criteria:

* Diagnosed with severe cardiac disease
* Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85.
* Type II DM with history of foot ulcers in the last six months prior to the study
* History of nerve damage not due to Painful Diabetic Neuropathy.
A Study of Pariet to Prevent Gastric and Duodenal Ulcer Associated With Low-aspirin in Korean Participants With a History of Gastric and Duodenal Ulcer

The purpose of this study is to understand the following safety related particulars associated with the use of Pariet Tablet 5 milligram (mg) to prevent gastric and duodenal ulcer from low dose aspirin administration of 100 mg or less daily in participants with a history of gastric and duodenal ulcer: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information.


Eligibility Criteria:
Inclusion Criteria:

1. Participants aged over 18 years
2. Participants who have a history of gastric and duodenal ulcer falling under the approved indication for Pariet Tablet 5 mg and who are receiving Pariet Tablet 5 mg to prevent gastric and duodenal ulcer from low dose aspirin use of 100 mg or less daily
3. Participants whose prescription of Pariet Tablet 5 mg has been determined before study participation
4. Participants who have given written consent to the use of their personal and medical information

Exclusion Criteria:

1. Participants with a known hypersensitivity to rabeprazole sodium, any excipients used in the formulation or benzimidazole derivatives, and with the history of such hypersensitivity
2. Participants administered with atazanavir
3. Pregnant or lactating
4. Participants administered with rilpivirine
5. Participants currently participating in other clinical trials
Reuptake of an E-Learning Programme in General Practice

The evaluate the use and diffusion of an E-learning programme in Diagnostic Evaluation of Dementia among General Practitioners (GPs) in Denmark.

The hypothesis are:

1. The GPs do not use the guided instructions
2. The GPs using the programme are more frequently younger GPs.
3. GPs working in rural areas will use the programme more frequently

In a period from november 2006 to may 2007 all log files of those GPs who log on to the E-learning programme are kept by the Danish Medical Association. They are handed over to the principal investigator in an anonymous form.

Eligibility Criteria:
GPs stopping working as GPs in study period
Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)

* Collect a large number of samples with certain / suspected diagnosis of collecting duct carcinoma in order to confirm the diagnosis (centralized review) and standardize according to WHO 2016 criteria
* Build an extensive tissue bank (DNA and RNA extraction) aimed at defining the molecular taxonomy of the tumor through 1) transcriptomic analysis 2) gene expression profile
* Define specific molecular signatures


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signature of consent (for patients enrolled in the prospective part of the study)
* Histological diagnosis of renal cell carcinoma of the Bellini collecting duct RCC

Exclusion Criteria:

-
Micro-surgical Treatment of Gummy Smile

Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.

The conventional approach: Anesthesia will be given followed by bone sounding using William graduated periodontal probe and measuring the pocket depth (using magnification loupes and microsurgical blades)

* Marking the bleeding points
* An internal bevel incision is made followed afterwards by a sulcular incision.
* The gingival collar is eliminated.
* Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery and an apical position of the bone 2-3mm beyond CEJ.
* Mattress suture (6.0) is made

The intervention approach:

Surgery is done the same as in the conventional approach but without opening a flap, gaining access via a tunneling instrument and piezo tips for osteoplasty

Eligibility Criteria:
Inclusion Criteria:

1. Patients with healthy systemic condition.
2. Adult patients ˃ 18 years old.
3. The presence of the six upper anterior teeth.
4. Patients who have short clinical crowns due to altered passive eruption classified as Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977).
5. Absence of sites with attachment loss and probing depth (PD) \>3 mm.
6. Keratinized gingiva of at least 2mm width (Pontoriero and Carnevale, 2001).
7. Compliance with good oral hygiene.
8. Patients accepts 6-months follow-up period (cooperative patients).
9. Patients provides an informed consent.

Exclusion Criteria:

1. Presence of prosthetic crowns
2. Extensive restorations
3. Extensive incisal edge attrition.
4. Smokers ˃ 10 cigarettes / day
5. Pregnant females
Utility of ICD Electrograms During Ventricular Tachycardia Ablation

With the increasing use of implantable cardioverter defibrillators (ICD) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an ICD is in place and the only documentation of the clinical arrhythmia will be the ICD electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained monomorphic VT represents a limitation when performing treatment with radiofrequency (RF) ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a reference "model" of VT with clinical expression consisting of the electrical signal of the ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This will allow for a more targeted approach to the substrate of the VT with clinical expression because: 1) if VT is induced by programmed stimulation, one can tell whether it is with clinical expression or not, and 2) if VT is not induced, ventricular pacing could be performed based on the comparative analysis of morphology and activation times of ICD-EG. These approaches will result in improved outcomes of the ablation procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clinical indication for RF catheter ablation
* Presence of an implanted ICD
* At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram
* Presence of structural heart disease
* Able to obtain signed informed consent and willing to comply with study activity requirements

Exclusion Criteria:

* It is anticipated that data can not be obtained during follow-up
* Unwilling or unable to provide informed consent
* Women who are or may potentially be pregnant
* Patients who are participating in another clinical trial
A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).


Eligibility Criteria:
Key Inclusion Criteria:

* Part 1: Heterozygous for F508del and an MF mutation (F/MF)
* Part 2: Homozygous for F508del (F/F)
* FEV1 value ≥40% and ≤90% of the predicted mean for age, sex, and height

Key Exclusion Criteria:

* History of clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* History of solid organ or hematological transplantation

Other protocol-defined Inclusion/Exclusion criteria may apply