cyrilzakka/clinical-trials huggingface dataset:
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.

Eligibility Criteria:
Inclusion Criteria:

* Males 18 -89 undergoing HoLEP
* Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence
* Willing to sign the Informed Consent Form
* Able to read, understand, and complete patient questionnaires.

Exclusion Criteria:

* Allergy or hypersensitivity to OnabotulinumtoxinA injections
* Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
* Anticipated need for perineal urethrostomy at the time of HoLEP
* Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy
* Patients who lack decisional capacity
* Active urinary tract infection
Clinical Trial to Evaluate the Efficacy and Safety of an Immunomodulatory Therapy for the Treatment of Patients With Moderate to Severe COVID-19 Infection

An Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe COVID-19 infection

The justification for the use of immunomodulatory therapy is based on the evidence that drugs that are inhibitors of interleukin IL6 may prevent the more severe lung tissue damage caused by cytokine release in patients with more severe COVID19. Several studies have suggested a "cytokine storm" caused by the release of IL-6, IL-1, IL-12 and IL-18 with tumor necrosis factor TNF alpha and other inflammatory mediators. Increased inflammatory response of lung tissue may result in increased gas exchange at the alveolar-capillary level making oxygenation difficult in patients with more severe forms of the disease and the need for mechanical ventilation. In this regard, it is hypothesized that the use of immunomodulatory therapy should have an effect in reducing the lethal outcome, the need for oxygen therapy, and mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with laboratory-confirmed (PCR) COVID-19 infection
* Patients with moderate to severe COVID-19 infection
* Hospitalized patients on clinical centers and cantonal hospitals
* Patients with radiology-confirmed pneumonia within the clinical condition of COVID-19 infection including pulmonary opacity
* Patients with a clinical indication for pneumonia: increased body temperature (defined as a value above ≥ 36.6⁰C axillary route, ≥ 37.2°C oral route or ≥ 37.8 °C rectal route), and/or dyspnea, and/or cough, and/or SpO2 \<96%
* Patients aged above 18, both genders
* Patients able and willing to understand the study, adhere to all study procedures and sign a written Informed Consent Form (ICF) prior to entering the study or with the assistance of the witness

Exclusion Criteria:

* Patients not COVID-19 positive
* Patients with mild COVID-19 infection
* Patients who are study subjects in another clinical study for another investigational agent for COVID-19
* Patients with malignant hypertension
* Patients with malignant disease and who are treated for malignant diseases in the last 5 years
* Patients with severe liver and kidney insufficiency
* Patients who are receiving therapy with an immunomodulatory or immunosuppressive agent
* Patients aged below 18, female patients who are pregnant or breastfeeding
* Known allergy to study drug or any component thereof
* Use of haloperidol, dopamine antagonists, or nonsteroidal anti-inflammatory drugs, except paracetamol.
A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers

This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two doses of AZD1446 or placebo in subjects when given for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-fertile female, elderly Subjects, aged ≥65 to ≤85
* Body mass index (BMI) between 18 and 30 kg/m2
* Clinically normal findings on physical examination

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History of severe allergy/hypersensitivity reactions including severe food allergy as judged by the investigator.
Metformin Effect on Fracture Healing in Post-Menopausal Women

study the effect of metformin drug on fracture healing of patients with high risk of delayed fracture healing or non-union and correlating this to serum irisin myokine level.

1. Approval will be obtained from Ethics Committee of general organization of teaching hospitals and institutes and Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
2. Getting informed consent from all participants to take part in this study.
3. Two groups each of 20 post-menopausal women with a bone fracture. One group will be treated randomly with metformin Retard 850 mg once daily for two weeks then 850 mg twice daily. The other group will be untreated and served as control group.
4. Venous blood samples will be taken from each patient before fracture stabilization and later for determination of serum irisin level with corresponding radiological evaluations.

Inclusion criteria:

• Age range from 55 to less than 65 years old with bone fracture.

Exclusion criteria:

* Age equal or less than 55 years
* Age equal or more than 65 years
* Unstable or hospitalized patients with heart failure
* Hepatic impairment
* Chronic kidney disease with eGFR \<45 mL/minute/1.73 m2
* Open fractures
* Pathological fractures
* Diabetic patients Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.

Methodology:

* Active Human Irisin ELISA kit will be used.
* Bone-specific Alkaline phosphatase BAP
* Serum creatinine, serum albumin, prothrombin time.
* Fasting insulin, fasting blood glucose and Calcium level.
* BMI, weight, waist, waist-hip ratio, total cholesterol and low-density-lipoprotein cholesterol.
* radiological scoring system will be used to evaluate the degree of new bone formation in the fracture line on anterior-posterior and lateral radiographs will be taken two months post stabilization.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 55 to less than 65 years old with bone fracture.

Exclusion Criteria:

* Age equal or less than 55 years
* Age equal or more than 65 years
* Unstable or hospitalized patients with heart failure
* Hepatic impairment
* Chronic kidney disease with eGFR \<45 mL/minute/1.73 m2
* Open fractures
* Pathological fractures
* Diabetic patients
Cytomegalovirus Spread and Reactivation in Blood Cells

To investigate the relationship between HCMV and bone marrow progenitor cells to understand whether HCMV is latent in CD34 + bone marrow progenitors and the mechanism by which the virus remains in a latent state.

BACKGROUND:

Despite progress in understanding the pathophysiology of human cytomegalovirus (HCMV) infections, its manifestations in the immune compromised host are frequently associated with high morbidity and mortality. In this setting, HCMV disease can develop e.g. following immune suppression as a result of reactivation of latent HCMV acquired earlier in life. The mechanisms leading to establishment of latent infections and their subsequent reactivation are not clear. It is also unknown whether HCMV exists in a latent form with limited viral gene expression or as a persistent infection with normal virus transcription.

DESIGN NARRATIVE:

The specific aims of the study were to: 1) examine the percentage of HCMV positive donors whose bone marrow progenitors contained HCMV DNA using nested PCR and determine if virus could be rescued from those cells. 2) Analyze the HCMV life cycle in hematopoietic progenitor and stem cells. 3) identify and analyze HCMV gene expression in in vivo infected leukocytes. Bone marrow progenitors containing HCMV DNA detectable by nested PCR were isolated from human donors and used as as source of mRNA to prepare Cdna libraries. 4) Determine if gene(s) expressed in bone marrow progenitors were important in either establishing or maintaining a latent infection or in the lytic cycle of HCMV. Information provided from the above studies yielded information important in planning future approaches for the therapy of HCMV infections.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.

The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria.
* Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant).
* Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening and baseline visits.
* Has an IGA score ≥ 2 at the screening and baseline visits.
* Has an Itch NRS score ≥ 4 at the screening and baseline visits.
* Willing to complete the once-daily Itch NRS (24-hour recall period) entries at approximately the same time each day during the study.
* Agrees to maintain a regular sleep schedule during the study period.
* Willing and able to follow required study procedures for measuring sleep for the duration of the study.

Exclusion Criteria:

* Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study.
* Currently has a schedule that includes nighttime work shifts.
* Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant).
* Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period.
* Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period.
* Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study.
* Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period.
* Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems.
* Has a known or suspected allergy to ruxolitinib or any component of the study drug.
A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Face Skin to Recover After Cosmetic Lasering

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery and reduction of skin redness after a dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars, open pores and change of pigmentation.

After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.

The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after non-ablative lasering on the face.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Eligibility Criteria:
Inclusion Criteria:

* Phototypes I or II according to the Fitzpatrick scale
* Participants willing to perform the dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea, poikiloderma, and melasma
* Normal eye examination

Exclusion Criteria:

* Cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation;
* Hyperpigmentation in the test area that intervenes with the evaluation of possible reactions
* Active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area
* Aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection
Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis

Traditional school scoliosis screening approaches remains debatable due to unnecessary referal and excessive cost. Deep learning algorithms have proven to be powerful tools for the detection of multiple diseases; however, the application of such methods in scoliosis screening requires further assessment and validation. Here, the investigators develop an artificial system for the automated screening of scoliosis using disrobed back images, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients included both pretreatment back photos and whole spine (C7-S1) standing X-ray or ultrasound images (for healthy population); 2. All the documents are clear to be recognized by naked eyes; 3. Back photos and are taken at the same time (not \>1month); 4.Patients were consider as idiopathic scoliosis according to clinical photos.

Exclusion Criteria:

* 1. Patients were considered as non-idiopathic scoliosis for obvious abnormal features of trunck,such as Cafe-au-Lait spots for neurofibromatosis, Spider finger, Abnormal hair spot of back, pelvic tilt, lower limb discrepancy and so on; 2.The taken time between back photo and X-ray or ultrasound was more than 1month; 3.The clinical photos and images were not clear; 4. The X-ray film or ultrasound images not including whole spine (C7-S1).
Improved Patient Recovery After Anesthesia With Hypercapnia Hyperpnoea

The proposed study will measure the time from the end of surgery until the time patients meet the discharge criteria from the postoperative anesthesia care unit and the time from the end of surgery until the patients regained cognitive function after anesthesia.

Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. In our first clinical study with isoflurane we confirmed that the time from turning off the vaporizer to opening of eyes was shortened by an average of 62% when the minute ventilation was elevated and the end tidal carbon dioxide concentration was kept at 52 mmHg rather than 28 mmHg during emergence. In our second study we found that hypercapnia and hyperpnoea accelerated recovery proportionately for sevoflurane and desflurane. The benefits of accelerating subject recovery in the operating room may extend to the entire recovery period if the subject is more alert and easier to care for when they arrive in the post anesthesia care unit.

Eligibility Criteria:
Inclusion Criteria:

* adults
* ASA class I-III
* both genders
* scheduled to undergo eye surgery at the Moran Hospital.

Exclusion Criteria:

* a history of renal or hepatic disease,
* chronic alcohol or drug abuse,
* disabling neuropsychiatric disorder,
* hypersensitivity or unusual response to other halogenated anesthetics,
* pulmonary hypertension,
* increased intracranial pressure,
* seizure disorder
* personal/familial history of malignant hyperthermia.
* currently being treated with known hepatic enzyme-inducing drugs (e.g., phenobarbital, dilantin or isoniazid)
* or with drugs known to alter anesthetic requirements (e.g., opiates, clonidine, alpha2 agonists, alcohol, anticonvulsants, antidepressants, barbiturates, benzodiazepines or other tranquilizers).
* intolerance to non-steroidal anti-inflammatories.
* have received general anesthesia within the previous 7 days,
* received any investigational drug within the previous 28 days,
* participated in a previous isoflurane or desflurane study
* Female subjects can be neither pregnant nor breast feeding.
A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.


Eligibility Criteria:
Inclusion Criteria:

* All participants must adhere to contraception restrictions
* Female participants of childbearing potential must adhere to contraception restrictions
* Have possible, clinically probable, clinically probable-laboratory supported or definite familial or sporadic ALS in accordance with the El-Escorial criteria or who have a diagnosis of ALS as defined by the Gold Coast Criteria; progressive motor impairment documented by history or repeated clinical examination, preceded by normal motor development, and presence of upper and lower motor neuron dysfunction in at least 1 body region or lower motor neuron dysfunction in at least 2 body regions and investigations excluding other conditions
* In familial ALS participants, a confirmed pathogenic superoxide dismutase 1 (SOD1) mutation
* Onset of symptoms (i.e, weakness) within past 24 months prior to screening, at the time of obtaining informed consent
* Have slow vital capacity (SVC) of greater than or equal to (\> or =) 50 percentage (%) of predicted values. Participants with SVC of \<50% of predicted values may be permitted to enter the open-label extension, based on the opinion of the investigator
* Absence of bilevel positive airway pressure (BiPAP)/proportional assist ventilation (PAV) \> 4 hours for symptoms attributable to ALS. Use of a CPAP for pre-existing conditions will be allowed
* If on riluzole, must be on a stable dose.
* If on edaravone, must have completed 2 cycles and are expected to remain on the same dose throughout the study
* Able to provide informed consent which includes compliance with the requirements and restrictions
* Have venous access sufficient to allow for blood sampling
* Have clinical laboratory test results within the normal reference range for the population or study site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria:

* Have participated or currently participating in another clinical trial within 12 weeks of baseline (Day 1)
* Have undergone a tracheostomy for ALS symptoms
* Are on nasal intermittent positive pressure ventilation (NIPPV) \>4 hours per day for the treatment of ALS related symptoms
* Have other causes of neuromuscular weakness
* Have cognitive impairment, severe disease in the cardiovascular, hematological, renal system, neurodegenerative disease, pulmonary disorder, or psychiatric illness
* Pregnant or nursing women
* Have been exposed to any antisense treatment targeting SOD1 within 6 months of the baseline visit
* Have undergone stem cell therapy
Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

The morbidity of colorectal cancer(CRC) is 10%～15% in China.mFolfox6 has become one of the standard regimes for metastatic colorectal cancer (mCRC). Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse effects which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity(OIN). But it did not certificated by phase III trial. Investigators designed the phase III trial to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at colorectal cancer.

it is a placebo controlled phase III trial. investigators plan to enroll 240 patients with 1:1 to A arm and B arm

Eligibility Criteria:
Inclusion Criteria:

1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;
2. age \>18 years old;
3. diagnosis mCRC with histology;
4. Did not received first-line chemotherapy
5. Karnofsky Performance scores \>70 scores
6. should have target lesions or non-target lesions
7. For patients received oxaliplatin before, the residual neurotoxicity should less than grade 2
8. For diabetes without neuropathy, blood glucose before meal should less than 8mmol/L and HBA1C\<7.0%
9. Patients should be expected to live no shorter than 3 months

Exclusion Criteria:

1. patients who is receiving chemotherapy;
2. WBC\<4.0×109/L，ANC\<1.5×109/L,PLT\<100×109/L，Hb\<90g/L,TBIL\>1.5Limitation;BUN）\>1.5Limitation；Cr）\>1.5Limitation；ALT or AST\>2.5Limitation（without liver metastasis）；ALT or AST）\>5Limitation（with liver metastasis）;
3. heart dysfunction;
4. brain metastasis;
5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
6. patients who received Glutathione, acetylcysteine, calcium / magnesium, amifostine, carbamazepine, B vitamins, vitamin E within 30 days