cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.


Eligibility Criteria:
Inclusion Criteria:

* The participant had symptomatic osteoarthritis (OA) in the target joint
* The participant had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria
* The participant, if female and of childbearing potential, must had a negative pregnancy test and had taken oral contraceptives for at least 1 month prior to treatment and continued for the duration of the study (up to and including the final study visit), or agreed to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise females must be surgically sterile, or postmenopausal for at least 1 year

Exclusion Criteria:

* The participant had symptomatic OA in the contralateral hip with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 numerical rating scale (NRS) score of ≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip was allowed)
* The participant if a woman was pregnant, lactating, or unwilling to use adequate contraception
* The participant had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening
* The participant had a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices
* The participant had a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen
* The participant had a known history of hypersensitivity to injected contrast agent at a previous radiological examination (e.g., computed tomography \[CT\] scan, angiogram, etc.), or known history of hypersensitivity to shellfish or iodine, or any other impediment to the hip injection procedure
* The participant had active infection in the area of the injection site
* The participant had any major surgery, arthroplasty or arthroscopy in the target hip or lower extremities within 26 weeks of Screening, or planned surgery in the lower extremities throughout the duration of the study infectious complications
* The participant used an investigational drug, device or biologic within 12 weeks of Screening
* The participant had any significant medical condition that the Investigator feels would interfere with study evaluations and study participation
Care of the Dry Skin With Physiogel AI Lotion® (W0156)

Dry skin is a physiological condition and is characterized in contrast to greasy skin by roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of tension, burning and itching can occur. Dry skin needs special care due to its structural and functional characteristics.We monitor an application test the Dermatocosmetics Oilatum Physiogel AI Lotion and Physiogel Lotion. This is to be accomplished with patients having dry skin. The influence on the roughness of skin, desquamation, feeling of tingle, burning and itching should be documented. If sleep quality is disturbed by tingle or itch, this will be monitored, too.

The included patients use the lotion twice daily for a two-week period. If not sufficient it can be continued up to a four-weeks period. Additionally, the patient receives a documentation sheets to note several parameters. In a sensory assessment, product specific parameter such as spreadability, permeability, lubricating, smell of lotion and cosmetic acceptance during the treatment will be assessed (at the beginning, after 2 weeks, after 4 weeks, 2 weeks after stopping treatment). After four weeks the skin care measurement will be terminated and the patient can continue with a treatment of his choice. A monitoring of at least 50 patients per preparation is intended.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age: over 18 years
2. Willing to apply skin care for 2 to 4 weeks, twice daily
3. Willing to fulfill questionnaires / home diaries: self-perception of roughness of the skin, desquamation of the skin, lack of skin brightness, feelings of tension and itching

Exclusion Criteria:

1. Participation in any other research study during the previous 4 weeks.
2. Previous participation in this study.
3. Concurrent participation in any other research study involving an investigational product.
4. Current need for the use of topical steroids.
5. History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients.
6. Subjects considered unable or unlikely to fulfill diaries.
7. Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
8. History of cancer.
9. Recent immunization (less than 10 days prior to the use of the test product).
Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy Subjects

The objective of this study is to evaluate the safety, tolerability, and efficacy of subretinal injection of NGGT001 in patients with Bietti Crystalline Corneoretinal Dystrophy (BCD) and to recommend the optimal dosage for future clinical administration.


Eligibility Criteria:
1. Age ≥ 18 years old.
2. Male or female.
3. Confirmed diagnosis of BCD.
4. Molecular diagnosis confirmed cytochrome P450 family 4 subfamily v member 2 (CYP4V2) mutation.
5. AAV2 neutralizing antibody titer \<1:5120.
6. 0.05 ≤ Best Corrected Visual Acuity (BCVA) ≤ 0.3.
7. -6.00D ≤ Refractive error ≤ +3.00D.
8. Agree to take contraceptive measures from the start of the study until one year after medication administration.
9. Volunteer to participate in the study and sign informed consent.

Exclusion Criteria:

1. There are choroidal neovascularization or other ocular diseases caused by BCD, which are considered to affect the operation or interfere with the interpretation of clinical endpoint.
2. Patients with evidence of neovascularization or suspected neovascularization, and the presence of tubular reflectivity in the neuroepithelial layer as shown by OCT.
3. Those who had used any of the treatment drugs within 6 months before enrollment, such as Lucentis, Avastin, Conbercept, Triamcinolone acetonide, etc. These may affect the experimental observation.
4. The treated eyes have undergone intraocular surgery, such as photodynamic therapy (PDT), vitrectomy, periocular vascular bypass surgery, etc., or need intraocular surgery in the process of clinical research, such as cataract surgery, retinal laser therapy, etc.
5. Have used or may use systemic drugs that may cause eye damage, such as psoralen, tamoxifen, etc.
6. Highly sensitive or allergic to ingredients in the test drug (with allergic history of two or more drugs or food).
7. Physical examination, vital signs, and laboratory examination (such as blood routine, urine routine, blood biochemistry, coagulation function, immunology examination, etc.) are abnormal and clinically significant, or the investigators believe that the abnormal indicators have clinical significance.
8. There are diseases or medical histories that may affect drug safety or in vivo processes, especially cardiovascular, liver, kidney, endocrine, digestive tract, lung, nerve, blood, tumor, immune or metabolic disorders considered by investigators to be of clinical significance.
9. Participated in clinical trials of other drugs or medical devices within three months before enrollment.
10. Female patients who are pregnant or lactating.
11. Any other conditions which lead the investigator to determine the participant is unsuitable for this study.
Pattern of Upper Gastrointestinal Lesions in Upper Egypt : Clinical, Endoscopic and Pathological Evaluation

Upper Gastrointestinal (UGI) symptoms are among the commonest complaints for which patients seek medical attention, with the annual prevalence of dyspepsia approximating 25% . Endoscopy holds an important place in the diagnosis of UGI conditions by enabling visualization, photography, ultrasonography, and biopsying of suspicious lesions . It gives a better diagnostic yield over radiology particularly in the investigation of upper gastrointestinal bleeding, inflammatory conditions of the upper gastro-intestinal track like esophagitis, gastritis and duodenitis as well as the diagnosis of Mallory Weiss tears and vascular malformations .Dyspepsia in the absence of any other symptom was the indication for UGIE in the vast majority of patients. Close to 80% of our patients presented with dyspepsia not associated with any other symptom and in 50% of the patients the endoscopic findings were normal \[4\]. Other common reasons for UGIE were GERD symptoms, recurrent vomiting, dyspepsia associated with weight loss and patients with symptoms of UGI bleeding . Gastritis was the most frequent endoscopic finding in our patients, followed by duodenitis .Gastric ulcer was diagnosed more frequently than duodenal ulcers . Taking a biopsy is very helpful in diagnosis in our study. H. pylori colonization of the gut is the main cause of chronic gastritis and the principal etiological agent of gastric cancer and peptic ulcer disease . Gastric cancer was diagnosed, by endoscopy, about eight times more frequently in patients presenting with an alarm symptom like recurrent vomiting, dyspepsia together with weight loss or UGI bleeding .


Eligibility Criteria:
Inclusion Criteria:

- All patient undergoing elective and urgent upper GIT endoscopy either therapeutic or diagnostic.

Exclusion Criteria:

* Patient undergoing endoscopic intervention for previously detected endoscopic lesion
Intelligent Pain Management System for Assessing Pain in Cancer Patients

The purpose of this study is to determine whether the Intelligent Pain Management System (IPMS) could make recording and interfering pain timely among cancer patients with pain. The system's usability, feasibility, compliance, and satisfaction will also be assessed.

Research indicate that over one-third of cancer patients experienced cancer pain, which is known as a major reason leading to lower quality of life of the patients.In this present study, the investigators aim to design, develop, and test the feasibility of a low cost, conveniently implemented mobile application to facilitate real-time pain recording and timely intervention among Chinese cancer patients with pain. This system evaluate real-time pain and Karnofsky Performance Status（KPS）scores for quality of life, and to generate an action plan to visit the physician or to adjust pain medication dosage when the pain threshold is reached. The investigators study is to test this system's effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* the patient was able to read Chinese and use smart phones;
* the patient was diagnosed with cancer and has self-reported cancer pain within a month prior to the study;
* the patient was being seen on a regular basis by the oncology team;
* the patient was under standard analgesia treatments;
* the patient was estimated to have over 3 months survival time.

Exclusion Criteria:

* the patients who self-reported to have severe cognitive impairments or major comorbid illnesses that would interfere with pain assessment.
A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers

Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.

Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And then the termination was decided by Pfizer on September 8, 2009 prior to subject dosing with PF-00868554. There were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female Japanese subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
* Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
* Pregnant or nursing females; females of childbearing potential.
Implementation of Smoking Cessation Support During Lung Cancer Workup

The aim of the present project is to implement smoking cessation support in hospital-based lung cancer workup. The effect on 1) patients' smoking cessation attempts, motivation, quality of life and psychosocial consequences of lung cancer workup as well as 2) hospitals' number of referrals to municipality-based smoking cessation programmes will be evaluated in a pragmatic, cluster-randomised controlled setup, where participating hospitals will be assigned to the intervention arm (implementation of smoking cessation support) or the control arm (usual practice). Patients' and healthcare professionals' experiences with and barriers towards smoking cessation support will be explored in an interview-based, qualitative study.


Eligibility Criteria:
Inclusion Criteria:

* Referred to lung cancer workup at participating hospital
* Able to speak and understand Danish

Exclusion Criteria:

* Unable to complete electronic questionnaires
Multiple Ascending Dose Study of SPC5001 in Treatment of Healthy Subjects and Subjects With FH

The purpose is to study Safety and Tolerability.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects and subjects with heterozygous Familial Hypercholesterolemia

   * Healthy male or female subjects, age 18 to 65 years, inclusive will be enrolled in Cohorts 1 through 4.
   * In Cohort 5, male or female subjects with heterozygous Familial Hypercholesterolemia, confirmed through genetic testing, without a history of cardiovascular disease (e.g. coronary artery, peripheral artery or cerebrovascular disease), hypertension or diabetes mellitus age 18-45 years, inclusive, will be enrolled.
2. BMI of 18-33 kg/m2
3. Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:

   * LDL ≥.3.24 mmol/L (≥ 100 mg/dL)
   * Triglycerides (fasted) \< 4.5 mmol/L (\< 398 mg/dL)
   * ALT within normal limits for healthy subjects and ALT \< 2 x ULN for FH subjects

Exclusion Criteria:

1. Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential

   - History or presence of malignancy within the past year is an exclusion criterion. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
2. Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
3. Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study. For the FH subjects statin therapy (and other lipid lowering therapies) will be prohibited within 4 weeks prior to the first study drug administration.
4. Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies. An exception can be made for medication or supplements that in the opinion of both the investigator and the Sponsor do not complicate or compromise the study or interfere with the study objectives.
5. Positive results on the following Screening laboratory tests: urine or serum pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White, Gloucester, UK) at 2-year follow-up.

Subjects will require to have at least two teeth in different hemiarchs with dentin hypersensitivity. Teeth will be randomized into 2 groups, receiving either Clinpro XT or the conventional glass ionomer cement Vidrion R. Prior to the desensitizing treatment (baseline), painful symptoms will be assessed by tactile and air blast tests using the Visual Analogue Scale (VAS). Treatment evaluations will be conducted up to 2-year post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 18 and 70 years old
* At least 2 teeth with dentin hypersensitivity in two different hemiarchs
* Dental elements with hypersensitivity without any pulp alteration
* People who are not taking any medication and women who are not pregnant
* Patients without eating disorders or very acidic diets.

Exclusion Criteria:

* Teeth with hypersensitivity that presented extensive or unsatisfactory restorations, fractures, periodontal alterations, caries lesions, orthodontic brackets, endodontic treatments, pulp alterations.
* Subjects who received any desensitizing therapy during the last 3 months
* Subjects being under analgesics/anti-inflammatory drugs at the time of the study
* Teeth with hypersensitivity and non-carious cervical lesions
Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure

This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.

This research study is being done so that investigators can understand the complex interactions between the heart, the lungs and the chest wall after heart surgery. Understanding this may guide future care that can help patients with their recovery from heart surgery.

The heart and lungs work together to make sure the body has the oxygen-rich blood it needs to function properly. The chest wall protects the heart, lungs, and other important organs. Investigators would like to learn how a patient's chest wall contributes to the heart and lungs interaction when the chest is left open after heart surgery.

Investigators will be using a device called an esophageal pressure catheter to estimate the pressure that is transmitted to the lungs and heart, called pleural pressure. Previous research has shown that this pressure measurement is used to adjust the breathing machine for patients with lung diseases. Measuring the pressure transmitted to the lungs and heart after heart surgery and delayed chest wall closure may help investigators understand how the chest wall contributes to the heart and lung interaction.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent provided by parent or primary guardian.
2. Aged \<28 days of life at the time of cardiac surgery.
3. Undergone surgery using CPB for congenital heart disease.
4. Undergoing DSC in CCCU.

Exclusion Criteria:

1. Gestational age \< 37 weeks or weight \< 2 kg at the time of surgery.
2. Endotracheal tube leak \>20%.
3. Need of extracorporeal support (ECMO), inhaled nitric oxide.
4. Pre-existing pulmonary disease (For example: Congenital diaphragmatic hernia).
5. Pre-existing or new arrhythmia that can impact hemodynamic assessment.
6. Severe coagulopathy or any other contraindication for the insertion of a nasogastric catheter (e.g., history of tracheo-esophageal fistula).
Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Subjects

The main purpose of this study is to compare the impact of low versus moderate-intensity aerobic training in post-COVID 19 older subjects.

On exercise adherence and changes in physical fitness, psychological status, and quality of life after a 10-week intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age range of 60 - 80 years with
* diagnosis of post-COVID-19

Exclusion Criteria:

* • History of lower limb surgeries, fractures

  * Cardiac problems
  * Respiratory problems
  * Neurological problems
  * Systemic problems and any other contraindications for aerobic training
LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse

We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with SLE that are clinically quiescent at inclusion Systemic Lupus Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. Current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with SLE disease activity

Systemic Lupus Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. Current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with SLE disease activity.

We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with SLE that are clinically quiescent at inclusion.

LUMIER² is a prospective multicentric observational study conducted in the departments of Clinical Nephrology, Internal Medicine and Rheumatology in the South of France. Adult patients with SLE, clinically quiescent and with no change in treatment in the past 3 months, will be included and followed-up for 12 months. Blood samples will be drawn every 3 months during 12 months in the absence of flare. Patients presenting a flare will be sampled at the time of the flare and 1 month later.

The inclusion of 300 patients is expected, with a test cohort (150 patients) and a validation cohort (150 patients).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* SLE defined by ACR criteria
* Clinically quiescent disease (SLEDAI =\< 4 without clinical flare) and absence of treatment increase in the past 3 months
* Written informed consent

Exclusion Criteria:

* Pregnancy, lactation
Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines

The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation expected to be required more than 48 hours
* Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
* Treatment with vasoactive drug administered via a central venous catheter
* Age over 18 years
* Signed information

Exclusion Criteria:

* Abdominal surgery within 1 month before inclusion
* History of esophageal, gastric, duodenal or pancreatic surgery
* Bleeding from the esophagus, stomach or bowel
* enteral nutrition via gastrostomy or jejunostomy
* pregnancy
* Treatment-limitation decisions
* Current inclusion in a trial on comparison between enteral and parenteral nutrition