cyrilzakka/clinical-trials huggingface dataset:
Effects of Celecoxib After Percutaneous Coronary Intervention

Several studies including ours have reported that celecoxib improves endothelium-dependent vasodilation and reduces inflammation and neointimal hyperplasia. Our hypothesis is that celecoxib may reduce the late luminal loss after coronary stent implantation (paclitaxel-eluting stent.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease with at least 1 de novo lesion greater than 50% stenosis on coronary angiography

Exclusion Criteria:

* Acute ST elevation MI
* Left main disease
* Contraindications to aspirin, clopidogrel or celecoxib
* Severe congestive heart failure
* Expected survival \< 2 years
* Hepatic dysfunction
* Currently taking NSAIDs or any COX-2 inhibitor
* Renal dysfunction
* Use of warfarin
Low Impact Laparoscopy Concept Versus Conventional Laparoscopy

Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS.

The feasibility and safety of laparoscopy is well established, particularly in the field of gynecology, but this technique often causes postoperative pain. Techniques are being developed to reduce postoperative pain in laparoscopic surgery. Low pressure insufflation (7 to 10 mmHg) compared to standard pressure insufflation (12 to 15 mmHg) significantly reduces postoperative pain. Microcoelioscopy (use of 3 mm trocars instead of 5 to 12 mm trocars in standard laparoscopy), by reducing the size of incisions, also significantly reduces postoperative pain.

The Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation and microcoelioscopy which would have the advantage of reducing postoperative pain. This technique would therefore, by reducing postoperative pain, to improve outpatient management, particularly in cases of hysterectomies for which the outpatient management rate could be increased.

The hypothesis is that using the Low Impact Laparoscopy concept would increase outpatient management rate compared to conventional laparoscopy in gynecological surgeries for hysterectomy.

The study aims to compare the Low Impact Laparoscopy concept with conventional laparoscopy in terms of ambulatory care rates in patients undergoing surgery for hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* women over 18 years
* planned surgery procedure : ambulatory laparoscopic hysterectomy
* effective contraception if women of childbearing age
* patients with free, informed and signed consent

Exclusion Criteria:

* disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
* pregnancy or wish for subsequent pregnancy
* lactating women
* contraindication to laparoscopy
* contraindication to minimally invasive endoscopic techniques
* not eligible for outpatient care
* inability to understand the information given
* a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.

Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
* Stage IV
* Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
* Absence or irradiated and stable central nervous system metastatic disease.
* Life expectancy of more than 3 months.
* Age ≥ 70 years.
* Performance status (WHO) ≤ 2.
* Adequate bone marrow function (Absolute neutrophil count \>1000/mm3, Platelet count \>100000/mm3, Hemoglobin \>9gr/mm3).
* Adequate liver (Bilirubin \<1.5 times upper limit of normal and SGOT/SGPT \<2 times upper limit of normal).
* Creatinine clearance (Cockcroft-Gault formula) \>30ml/min.
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
* Presence of a reliable care giver.
* Informed consent.

Exclusion Criteria:

* Prior chemotherapy for metastatic disease.
* History of thromboembolic disease or myocardial infraction within the last 6 months.
* Peripheral neuropathy ≥ grade 2.
* Bowel obstruction or chronic diarrhea.
* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Other concurrent investigational agents.
Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers

This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. For change of intestine environment, especially the gut microbiota, investigators will administer PO vancomycin for 7 days, tid.


Eligibility Criteria:
Inclusion Criteria:

* Age between 19 Y to 50 Y at the screening
* Body weight over 55 kg and BMI should be between 18.0 to 25.0 kg/m2
* Informed consent will be taken before all the procedures from volunteers
* SLCO1B1 genotype is \*1/\*1 when screening

Exclusion Criteria:

* No significant disease history or ongoing disease
* Allergic to simvastatin and vancomycin, or similar affiliation drug for simvastatin or vancomycin
* MDRD eGFR less than 60 mL/min/1.73m2
* Total cholesterol, LDL, TG is higher than 1.5 times more than upper normal limit at the screening
* HDL less than 35 mg/dL at the screening
* Positive HBV or HIV or HCV
* Who is administering or going to administer CYP3A4 inihibitor drug
* Other clinically significant situation under doctor's opinion
Factors on Therapeutic Drug Monitoring and Safety of Voriconazole in Critically Ill Elderly Patients

This was a prospective clinical study that all voriconazole-treated adult Chinese patients with invasive pulmonary infection admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from July 2018 to June 2023. The initial voriconazole serum trough concentration, Correlation of various factors, and risk prediction factors for voriconazole serum trough concentration and hepatotoxicity were compared between elderly and non-elderly patients.

A prospective observational study was conducted from July 2018 to June 2023 in Zhengzhou Central Hospital Affiliated to Zhengzhou University. This study was carried out in accordance with the following criteria: (1) patients who met the criteria for diagnosis of IFI, (2) age ≥ 18 years, (3) The duration of VCZ treatment course ≥ 7 days.

Patients were excluded who fulfilled any of the following criteria: (1) Patients who allergic to VCZ, (2) use other anti-fungal drugs during the use of VCZ, (3) do not qualify for blood sampling monitored by blood concentration, (4) pregnant or lactating women, (5) patients who haven't completely and accurately efficacy and safety data, (6) patients who are treated with a combination of liver enzyme inducers and inhibitors (carbamazepine, phenobarbital, phenytoin, cimetidine, rifampin, rifapentine, rifabutin, and so on),(7) patients who are treated with a combination of Paxlovid or Azvudine.

Grouping: Patients were divided into the elderly group (group A, ≥ 60 years) and the non-elderly group (group B, \< 60 years) according to ages. All the recruited patients were treated with voriconazole. Voriconazole was intravenously administered 2 times at the loading dose of 6 mg/Kg or orally administered 2 times at the loading dose of 400mg at 12h intervals, followed by a maintenance dose of 4 mg/Kg or 200 mg at 12 h intervals.

Eligibility Criteria:
Inclusion Criteria:

* patients who met the criteria for diagnosis of IFI
* age ≥ 18 years
* The duration of VCZ treatment course ≥ 7 days.

Exclusion Criteria:

* Patients who allergic to VCZ
* use other anti-fungal drugs during the use of VCZ
* do not qualify for blood sampling monitored by blood concentration
* pregnant or lactating women
* patients who haven't completely and accurately efficacy and safety data
* patients who are treated with a combination of liver enzyme inducers and inhibitors(carbamazepine, phenobarbital, phenytoin, cimetidine, rifampin, rifapentine, rifabutin, and so on)
* patients who are treated with a combination of Paxlovid or Azvudine.
Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis

Plantar fasciitis is one of the most common causes of heel pain. This study will be performed in the purpose of determination the effects of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis

Plantar fasciitis is the most common cause of inferior heel pain, A great variety of therapies have been reported for the treatment of plantar fasciitis including extracorporeal shock wave therapy. Gastrosoleus muscle dysfunction is one of the most common contributing factors to this disease .Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there is lack of high-quality studies demonstrating the efficacy of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis , this study will be performed to examine the effect of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of plantar fasciitis
2. having at least one Gastrosoleus trigger point concomitantly.
3. having no response to conservative treatments for at least 3 months
4. willingness to participate

Exclusion Criteria:

1. Dysfunction of the knee or ankle
2. Neurologic abnormalities
3. Bleeding tendency (hereditary or acquired)
4. Nerve entrapment syndrome
5. A previous operation on the heel
6. Pregnancy
7. Evidences of Infection in lower limbs
8. A medical History of tumor
9. previous local corticosteroid injection within 12 weeks
Doppler Sonography, MR Venography, Plethysmography for the Diagnosis of CCSVI

This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography and air-plethysmography for the assessment of abnormalities in the internal jugular veins, with catheter venography as the reference test.


Eligibility Criteria:
1. Patients group

   Inclusion Criteria:
   * confirmed diagnosis of multiple sclerosis

   Exclusion Criteria:
   * coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
   * significant stenosis of carotid or vertebral arteries
   * other significant abnormalities of blood vessels of the upper part of the body
   * tricuspid valve incompetence
   * allergy to iodine contrast dye
   * chronic renal failure
   * pregnancy
   * other severe comorbidities or significant abnormalities in standard lab tests
2. Healthy volunteers.

Inclusion Criteria:

* none

Exclusion Criteria:

* confirmed diagnosis of multiple sclerosis or related pathologies (CIS, NMO)
* coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
* significant stenosis of carotid or vertebral arteries
* other significant abnormalities of blood vessels of the upper part of the body
* tricuspid valve incompetence
Photocil (Topical) for the Treatment of Atopic Dermatitis

Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of atopic dermatitis.

NB-UVB phototherapy is a common treatment for patients with atopic dermatitis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Atopic Dermatitis Area Severity Index (ADASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.

Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.

In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with atopic dermatitis confirmed by a dermatologist
* Atopic dermatitis lesions affecting at a minimum 5% of the facial, legs, or arms surface area
* Age: 18 to 65
* Participants able to give informed consent

Exclusion Criteria:

* Subject did not respond to prior phototherapy treatment
* Subject completed phototherapy for same lesion(s) in last 6 months
* Subject has previous history of skin cancer
* Subject has previous history of photosensitivity
* Subject has a history of herpes (HSV I or II) outbreaks
* Subject has previous history of autoimmune disease may be excluded at investigator's discretion
* Subject is currently taking of immunosuppressive or photosensitizing drugs
* Subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. These patients may be excluded at investigator's discretion
* Subject is pregnant or lactating women
Minimum Dose CT Post Lung Biopsy

The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of patients post Lung Biopsy

Patients post Lung Biopsy have a chest X-ray (CXR) and a MnDCT post lung biopsy. Both studies are compared for the detection of a pneumothorax

Eligibility Criteria:
Inclusion Criteria:

* All Patients having a lung biopsy

Exclusion Criteria:

* None
Pulmonary Involvement in Patients With Fabry Disease

The objective of this study is to investigate whether Agalsidase alpha, a drug commonly prescribed in patients with Fabry disease, is associated with improvement of the pulmonary involvement. According to the Global Initiative for Obstructive Lung Disease (GOLD), the surrogate markers for obstructive lung diseases are a decrease in both forced expiratory volume in one second (FEV1) and FEV1/FVC ratio, whereas FVC is the forced vital capacity. However, the measurement of these lung function parameters is indicated as yearly follow-up examinations with or without the treatment of Agalsidase alpha in patients with Fabry disease.

Pulmonary function tests und DLCO measurements are performed yearly in relation with yearly follow up examinations in the Department of Internal Medicine from the University Hospital of Zurich. We will retrospectively collect the results of the pulmonary functions test (spirometry).

Eligibility Criteria:
Inclusion criteria:

* All patients with established diagnosis of Fabry disease

Exclusion criteria:

* Missing informed consent
Effects of Maitland's Antero-Posterior Versus Lateral Mobilizations on Cardiovascular Responses

This study will be a randomized control trial and will be conducted in Polyclinic Hospital Islamabad \& Rawal Dental and General Hospital Rawalpindi. A sample of 62 participants will be taken. Patients will be divided into two equal groups of 31 participants in each group, group Randomization will be done through flip coin method. Patients in group A will receive Maitland's antero-posterior Mobilization, while Patients in group B will receive Maitland's lateral mobilizations. 4 sessions of treatment will be given for 2 weeks with interval of 3 days, 4 days and 7 days between 1st \& 2nd session, 2nd \& 3rd session and 3rd \& 4th session, respectively. The outcome measures will be OMRON Automatic Blood Pressure Monitor, Numeric pain rating scale(NPRS) and Global Rating of Change questionare will be measured at baseline and at the end of 4th session. Data will be analyzed by SPSS 25.


Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category would be recruited into the study.
* Age 25 to 55 years
* Pain in neck with no known cause for \> 3 months
* Resting systolic blood pressure between 90 to 139 mmHg
* resting diastolic blood pressure between 60 to 88 mmHg
* resting heart rate between 60 to 100 beats/min
* no prior exposure to antero-posterior and lateral mobilizations

Exclusion Criteria:

* Participants falling in this category would be excluded from the study.
* age \<25 and \>55
* current smokers
* history of fainting spells, diabetes mellitus, spinal surgery and whiplash injury( in last 6 months)
* taking medications for blood thinning, diabetes mellitus
* having neurologic or cardiovascular disease, radiating pain, cervicogenic headaches
* movement coordination impairment
* athletes
* unable to read and write
Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)

The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).

This study will be conducted in two stages. Stage 1 is a 48-week, dose-escalation, open-label evaluation of AR-14034 SR. Two cohorts will be enrolled, for an approximate total of 10 subjects. Subjects in both cohorts will attend visits through Week 48 for assessment of safety and preliminary treatment effects.

Stage 2 is a 56-week (plus extension) double-masked, active comparator, randomized, parallel group evaluation of AR-14034 SR compared with aflibercept. Approximately 130 subjects will be enrolled and randomized 2:2:1 to AR-14034 SR lower dose, AR-14034 SR higher dose, or aflibercept dosed as labelled. Subjects will attend visits through Week 56 for assessment of safety and treatment effects. A 16-week open label extension phase will be conducted thereafter.

Eligibility Criteria:
Key Inclusion Criteria \[Stage 1 and Stage 2\]:

* Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD);
* Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye;
* BCVA greater than 34 letters (approximately 20/200 Snellen equivalent) in the non-study eye;
* Media clarity and pupillary dilation in the study eye sufficient for all planned study procedures;
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;
* Other protocol-specified inclusion criteria may apply.

\[Stage 1\]:

* Greater than or equal to 3 and less than or equal to 6 prior treatments of an ocular anti-VEGF medication within the 8 months prior to Screening in the study eye, with demonstrated anatomic response, as assessed by the Investigator.

\[Stage 2\]:

* Treatment-naïve, or initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye within 9 months before Screening.

Key Exclusion Criteria \[Stage 1 and Stage 2\]:

* History or current ocular disease in the study eye other than nAMD, that, might require medical or surgical intervention during the study;
* Structural damage to the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the nAMD;
* Any active intraocular or periocular infection or active intraocular inflammation;
* Treatment with ocular anti-VEGF product within 28-days before Week -1 \[Stage 1\] or Baseline \[Stage 2\];
* Uncontrolled glaucoma in the study eye;
* Uncontrolled blood pressure;
* Females of child-bearing potential who are pregnant, intending to become pregnant, nursing, or who are not willing to use an acceptable form of contraception for the duration of the study;
* Other protocol-specified exclusion criteria may apply.
Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)

Randomized, double blind, parallel study to assess the effect of a dietary supplement combining polyphenols (hydroxycinnamates from green coffee) and a soluble dietary fiber (oat beta-glucans) in obese/overweight subjects.

This pilot study intends to select the best combination of beta-glucan and a green coffee bean phenolic extract. Four different supplements were formulated, containing 3 or 5 g of two types of beta-glucan, with 35% and 70% b-glucan content, together with 600 mg of the green coffee bean extract. Blind sachets were prepared containing half the daily dose of the supplement.

60 overweight/obese male and female volunteers (BMI 25-35 kg/m2, 18-60 y old) were recruited and randomly assigned to one of the four intervention groups. Volunteers were instructed to consume one sachet half an hour before lunch and dinner dissolved in 250 mL water daily during 6 weeks.

At the beginning and at the end of the study, volunteers came to the Human Nutrition Unit at the research center after an overnight fast. Urine and blood samples were obtained, blood pressure was measured and anthropometric measurements were performed. Dietary and physical activity records were collected.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese subjects (BMI 25-35 kg/m2)

Exclusion Criteria:

* Smokers
* Pregnant women
* Medication/consumption of vitamins, dietary supplements, etc.