cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent and comply with the study protocol;
* Participant must be ≥40 to ≤80 years of age at the time of signing informed consent.
* Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease(COPD) and a history of COPD ≥12 months with medical records or related records at the time of screening;
* Post-bronchodilator FEV1/Forced vital capacity (FVC)\<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \< 80% during screening.
* Modified Medical Research Council (mMRC) Dyspnea Scale grade≥2 during screening.
* Background triple therapy (ICS+long-acting beta-agonists (LABA)+LAMA) for at least 3 months with a stable dose for at least 1 month prior to randomization; Double therapy allowed if ICS is contraindicated.
* With a history of acute exacerbation of ≥2 moderate or ≥1 severe within the previous 12 months prior to screening.

Exclusion Criteria:

* COPD with asthma;
* Subjects with active pulmonary diseases other than COPD assessed by the investigator.
* Moderate to severe Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) occurred within 4 weeks prior to screening or during screening;
* History of lung transplantation;
* Previous use of TQC2731.
* Diagnosis of alpha-1 anti-trypsin deficiency;
* History of lung volume reduction surgery or pneumonectomy within 6 months prior to randomization, or planned lung volume reduction surgery during the study period;
* Positive hepatitis B surface antigen, or hepatitis C virus antibody, or syphilis antibody.
* Diagnosis of immunodeficiency, including but not limited to HIV infection;
* Infection requiring systemic therapy within 2 weeks prior to randomization.
* Starting rehabilitation within 4 weeks prior to randomization, or planned rehabilitation during the study period;
* Treatment with oxygen of more than 12 hours per day.
* Heart failure New York Heart Association (NYHA) class III or IV during the screening period.
* History of malignancy within 5 years prior to screening, excluding cervical carcinoma in situ, ductal carcinoma in situ, etc.
* Pregnancy or breastfeeding.
Laparoscopic Bariatric Surgery: Impact of Deep Neuromuscular Block on Surgical Conditions

The purpose of this study is to determine whether deep neuromuscular blockade compared to moderate neuromuscular blockade may improve the surgical conditions in patients undergoing laparoscopic bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* patient between 18 and 64 years
* indication for bariatric surgery accordingly to HAS
* patient undergoing laparoscopic or robotic gastric bypass surgery
* written informed consent
* affiliation to social security

Non-inclusion Criteria:

* known hypersensibility to any of the drugs used during this study
* absence of written informed consent
Prenatal Starting Early Program mHealth

The purpose of this interventional trial is to test the efficacy of the remote delivery of the StEP:Prenatal intervention compared to standard prenatal care in pregnant individuals planning to receive prenatal and pediatric care at Bellevue Hospital. The primary aims are to determine the efficacy of the remotely delivered StEP:Prenatal intervention on diet, lifestyle behaviors, social determinants of health (SDoH), and pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant in the first trimester (up to 13 weeks, 6 days)
* Speak English or Spanish fluently
* Intent to receive prenatal and pediatric care at Bellevue
* ≥18 years
* Have a smart phone or device with internet access
* Willing and able to provide consent

Exclusion Criteria:

* Severe illness (severe medical or mental health condition e.g. cancer, epilepsy neuromuscular disease, psychosis or bipolar disorder).

Note: Diabetes, hypertension, depression are not excluded.

* Living in a shelter
* Receiving treatment for drug or alcohol use
Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies

This was a multicenter, uncontrolled, open-label, special drug use study to investigate the safety and efficacy of Xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic rhinitis aged ≥ 12 years and \< 18 years whose symptoms were inadequately controlled despite to conventional therapies and used Xolair.

The observation period lasted for up to 24 weeks, with Day 1 defined as the start date of Xolair treatment. It should be noted that, because the duration of Xolair treatment depends on the pollen dispersal situation and other factors, patients who completed or discontinued Xolair treatment before the visit at 24 weeks after the start of treatment were followed up until the date of last dose of Xolair + 30 days, and the results were recorded in the CRF.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who used Xolair in accordance with the instructions of package insert
2. Patients aged ≥ 12 years and \< 18 years at the start of Xolair
3. Patients who used Xolair for the following indication:

Indication: seasonal allergic rhinitis (only patients with severe to most severe symptoms whose symptoms were inadequately controlled despite to conventional therapies) 4. Patients having provided written consent to participate in this study before the start of Xolair in the relevant pollen season, in person and from their legally acceptable representative (legal representative)

Exclusion Criteria:

1. Patients with a history of hypersensitivity to any of the Xolair ingredients
Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars

This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with different epinephrine concentration in patients undergoing surgical extraction of impacted lower third molars


Eligibility Criteria:
Inclusion Criteria:

* Age over 19
* Physical grade 1 or 2 by American Society of Anesthesiologists (ASA)
* Mesioangular or horizontal angulation categorized by winter classification

Exclusion Criteria:

* Allergy or hypersensitivity about the investigated products
* Any infection or edema during the extraction
* The following patients: clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders
* Pregnancy or breast-feeding
* Any conditions that the investigator considers not to appropriate for this study
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, age 18 years or older.
* Presence of measurable disease that has been confirmed by histology or cytology.
* Must not be a candidate for potentially curative therapy or standard-of-care approved therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

* Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.
* Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
* Laboratory and medical history parameters outside Protocol-defined range.
* Known additional malignancy that is progressing or requires active treatment.
Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome

The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome

The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

Eligibility Criteria:
Inclusion Criteria:

* Pain associated with shoulder impingement syndrome in a single shoulder
* Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder
* Have positive Hawkins and Neers signs

Exclusion Criteria:

* Have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline visit
* Have used any injected pain medication within 14 days preceding the Screening/Baseline visit
* Are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
* Have a history of and/or past diagnosis of severe hepatic disease

Other protocol-defined inclusion/exclusion criteria may apply
Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt

This study evaluates the effect of regulating salt and protein intake on urinevolume in patients with ADPKD treated with a vasopressine V2 receptor antagonist (V2RA). The investigators hypothesize that changing sodium and protein intake will reduce V2RA-induced polyuria.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is characterized by the formation of numerous cysts in both kidneys and progressive renal function decline leading to renal replacement therapy (RRT) at a median age of 58 years. The first (and at the moment only) drug to slow down renal function decline, is a vasopressin V2 receptor antagonist (V2RA). This medicament slows renal function decline by 26 to 34%. V2RA also causes aquaresis associated side-effects such as polyuria of \>6 liter per day in the majority of patients. These side-effects limit wide spread use among ADPKD-patients. Therefore, there is a need to improve its tolerability. While using a V2RA, urine concentrating ability is strongly diminished. Therefore, urine volume is largely determined by total osmolar excretion. This is a well-known fact in nephrogenic diabetes insipidus, a disease with clear pathophysiological similarities to treatment with a vasopressin V2 receptor antagonist (a defect receptor versus pharmacological blockade). A recent study found osmolar excretion to be associated with urinary volume during V2RA treatment. Whether a change in osmolar load changes polyuria during V2RA has not yet been investigated. The investigators hypothesize that changing sodium and protein intake will reduce polyuria.

Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of ADPKD (ravine criteria/documented by nephrologist)
2. Stable treatment regimen of tolvaptan as part of routine clinical care in the highest dose tolerable (preferably 120 mg daily), with a urine osmolality lower than 250 mosmol/L.
3. Age \>= 18 years.
4. eGFR \>30 ml/min/1.73m2.
5. Providing informed consent.
6. Compliance to the recommended diet at two consecutive times.

Exclusion criteria:

1. Patients who, in the opinion of the investigator may present a safety risk.
2. Patients who are unlikely to adequately comply to the trial's procedures (due for instance to medical conditions likely to require interruption or discontinuation, history of substance abuse or non-compliance).
3. a. Patients taking medication likely to confound endpoint assessments:

   * lithium in any dosing regimen;
   * chronic use of systemic corticosteroids in any dosage;
   * chronic use of any diuretics in any dosing regimen;
   * daily use of any NSAIDs in any dosing regimen;

3. b. Patients having concomitant illnesses likely to confound endpoint assessments (e.g. diabetes mellitus for which medication is needed or diabetes insipidus).

4. Women who are pregnant or breastfeeding. 5. Patients with a blood pressure over 160/100 mm Hg at baseline.
Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)

Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis

This study will evaluate 24 patients with calcified NCC and edema in three treatment arms to compare the reduction in edema volume

Eligibility Criteria:
Inclusion Criteria:

* Calcified NCC
* Perilesional edema on CT or MRI
* Normal lab values

Exclusion Criteria:

* Viable neurocysticercosis
* Status epilepticus
* Symptomatic intracranial hypertension
* Tuberculosis
* More than 7 days after seizure
* Pregnancy
Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG)

This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product and will provide performance data on the Volume Guarantee function of the fabian ventilator in daily clinical routine.

PaVoG study is a prospective, multicenter, single-cohort post market observational study.

The study procedures will be conducted according to standard of care of each participating hospital and the instructions for use of the study device.

To allow data collection, an Informed Consent Form will be obtained from each study participant/ legally authorized representative, if required by the local Ethical Committee. Ventilator data will be recorded in the hospital's data capture system or on a study laptop provided by the Sponsor.

Each patient will be clinically evaluated according to hospital standard of care. If inclusion and exclusion criteria are met, and the investigative team is available the patient will be enrolled.

Study duration for an individual patient will differ, depending on the time spent on fabian ventilator with Volume Guarantee mode on.

It is anticipated that for most will be between 2-4 days.

Eligibility Criteria:
Inclusion Criteria:

* Patient ventilated with fabian ventilator (conventional or HFOV) with VG mode active.
* The anticipated use of VG mode is at least 12 hours
* Informed Consent given by parents or guardians according to the process approved by the local research ethical committee

Exclusion Criteria:

* Patients with severe airflow obstruction and intracranial hypertension
* Decision documented to give palliative neonatal care.
* The clinical care team does not agree with inclusion of the infant to the study
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies

RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies

A study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the MRI studies in Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine MRI.

Eligibility Criteria:
Inclusion Criteria:

* Age 1 month to 18 years
* Receiving a brain or spine MRI with propofol sedation
* Deemed safe to undergo sedation with propofol based on a pre-sedation examination
* Patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications

Exclusion Criteria:

* Patient below or above set age limits.
* Patient requires MRI studies on other body areas.
* Patient requires pre-medication with a sedative or tranquilizer
* Patient requires additional medications during sedation to complete the procedure.
* Propofol is being used as a rescue sedative to complete the procedure.
* Propofol is being used as a rescue sedative to complete a procedure that was initiated by another sedative.
* Patients who develop complications that require termination of the imaging procedure will not be included in the dose or recovery time calculations, but the complication will be counted as such in their respective group and study will be reported as non-diagnostic.
* Insulin dependent diabetes
* Thyroid disease
Red and Processed Meat Effects on the Metabolome and Microbiome

This controlled feeding trial will identify biomarkers in the metabolome and microbiome that may differ when consuming a healthy diet with or without red and processed meat.

This is a randomized cross-over feeding trial to test whether red and processed meat consumption, in the context of a controlled diet based on HEI-2015, will cause shifts in the metabolome and the microbiome compared to a controlled HEI-2015 diet with no red or processed meat. Twenty healthy adult volunteers will consume two diets in random order: 1) Diet A is based on the Healthy Eating Index-2015 (HEI-2015) and includes no red or processed meat; 2) Diet B is based on the Healthy Eating Index-2015 and includes red and processed meat (HEI-2015-M) as some of the protein sources. Both diet periods last 21 days and an approximately 21-day washout period occurs between diets.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult,
* 18-50 years of age,
* able to read, speak, and understand English, and
* willing to come to the Fred Hutchinson Cancer Research Center campus twice weekly during study

Exclusion Criteria:

* known allergy to red or processed meat,
* vegetarian or vegan,
* any religious or personal reason(s) to avoid red and processed meat,
* pregnant an/or exclusively breastfeeding, and/or
* alcohol or recreational drug abuse
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.

The trial was performed as a nonconfirmatory randomized controlled pilot trial with 200 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 5-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 5-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

Severe renal secondary hyperparathyroidism

Exclusion Criteria:

Patients with diabetes a history of chronic inflammatory disease a history of malignant tumor a history of kidney transplantation a history of neck surgery a history of alcohol abuse a history of drug abuse inability to cooperate with the participants refusal to participate in the study
Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment

This multicenter, randomized, double-blind study will evaluate the efficacy and safety of Toripalimab (JS001) combined with nab-paclitaxel compared with placebo combined with nab-paclitaxel for first/second line treatment of metastatic or recurrent triple-negative breast cancer (TNBC).


Eligibility Criteria:
Inclusion Criteria:

Metastatic or recurrent triple negative breast cancer (TNBC);

* Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);
* Eligible for taxane monotherapy;
* No more than one line of chemotherapy in metastatic setting;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Life expectancy of 12 weeks or more;
* At least one measurable lesion per RECIST v1.1;
* Demonstrate adequate hematologic and organ functions as defined in the protocol

Exclusion Criteria:

Prior treatment with taxane as first line treatment;

* Prior treatment with PD-1 antibody, PD-L1 antibody, PD-L2 antibody, or CTLA4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway)
* MRI assessment during screening or previous imaging studies confirmed active or untreated brain metastases. Patients previously treated with local treatment of brain metastases has been stable for ≥ 1 month, and have stopped systemic hormonal therapy (\>10 mg/d prednisone or equivalent) \> 4 weeks before randomization can participate in the study;
* Meningeal carcinomatosis;
* Pregnancy or lactation;
* Active hepatitis B or hepatitis C.
Effect of Virtual Reality on Functional Fitness and Quality of Life of Older Population

The purpose of this study is to assess the influence of virtual reality (VR) on the different parameters, happiness, quality of life and functional fitness, among older population. The study aims to conduct a randomized controlled trial, where the participants in intervention group will use VR and those in control group do not use VR.

This study aims to conduct a randomized control trial, on 60 older age group participants, and perform the functional fitness test based on the protocol developed by Rikli and Jones, before and after the VR intervention. The functional fitness tests include evaluation of upper body strength, lower body strength, cardiorespiratory endurance, upper body flexibility test, lower body flexibility test, balance, agility test. They will be randomly assigned to the intervention group, receiving the VR program, and the control group who will not receive the VR program. The participants in the intervention group will be asked to use the VR device for 15 minutes, twice a week for 6 weeks, along with their daily routine activities. Control group will carry out the daily routine activities, without the intervention. The change in the quality of life (QOL) and happiness, for both control and intervention groups, will be assessed through EuroQol 5 dimensions 3 level questionnaire (EQ-5D-3L), mini version of Chinese happiness Inventory questionnaire, respectively, to filled at recruitment and follow-up after 6 weeks. The effect of the VR programs will be determined by the comparison of performance, for the functional fitness tests before and after the intervention and also, for the differences between the control and intervention groups

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 60 years or older and approach TMU aging center.
* Able to understand Mandarin Chinese.
* Gives informed consent to participate
* No past or current history of serious medical disease
* Ability to perform activities of daily living
* Understands the intent of the study

Exclusion Criteria:

* Participants aged below 60 years of age.
* Not able to understand Mandarin Chinese.
* Does not gives informed consent to participate
* Past or current history of serious medical disease
* Inability to perform activities of daily living
* Does not understand the intent of the study