cyrilzakka/clinical-trials huggingface dataset:
Optical Coherence Tomography (OCT) in Retinal Vasculitis

Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the retina, the tissue that lines the inside of the eye. This inflammation may occur on its own or as a result of an infectious, cancerous, or inflammatory disorder.

Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves.

The purpose of this study is to see if non-invasive OCT technology can diagnose retinal vasculitis as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. The study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of retinal vasculitis

Exclusion Criteria:

* Inability to give informed consent.
* Inability to complete the qualifying study tests within a 30 day period from date of enrollment
* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* A prior history of reaction to fluorescein or other dyes.
* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
* Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
* Systemic anti-vascular endothelial growth factor (VEGF) or pro-VEGF treatment within 4 months prior to treatment.
* Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography.
* Prior panretinal photocoagulation (PRP) or focal laser that would alter the macular perfusion and retinovascular features.
* Inability to maintain stable fixation for OCT imaging.
* Other ocular condition is present such that, in the opinion of the investigator, may alter the retinal perfusion.
* An ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (i.e. cataract)
* Substantial cataract that, in the opinion of the investigator, is likely to decrease visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 20/40 or worse if the eye was otherwise normal).
* Media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner.
* History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc) within prior 4 months.
Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making

In 2015 the Danish healthcare authorities initiated major changes in the follow-up (FU) program for patients with ovarian cancer. The new FU program argues that there is no effect of routine monitoring, and every patient's FU is now individualized. These changes have caused major concern, especially regarding the omission of routine examinations aimed at detection of recurrence, since clinical symptoms of relapse can be diffuse. Clearly, tools and FU plans to support the patients in feeling safe during FU are of vital importance.

Patient-reported outcome measures (PROM) is a tool to improve the focus on patients' needs, symptoms and preferences. It is also a tool to monitor quality of life (QoL), and side effects.

300 patients with ovarian cancer are planned to be enrolled after primary treatment when they enter follow-up program. This is a multi-center study.

All participants fill in a questionnaire at baseline and then every 3 months for two years, and every 6 months the third year. The questionnaire consists of EORTC-QLQ-C30, EORTC-OV28, and questions on symptoms of relapse. At baseline the questionnaire is extended with demographic issues.

The patients will also fill in a brief questionnaire (CollaboRATE) dealing with patient satisfaction and the level of shared decision making experienced.

All participants are followed for 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age.
* Histologically confirmed epithelial ovarian, fallopian tube or serous primary peritoneal cancer.
* Have completed their first line treatment, with complete remission.
* Manage to read and speak Danish.
* Can receive active anti-cancer treatment such as maintenance bevacizumab

Exclusion Criteria:

•Have recurrent disease after first line treatment.
Physiotherapy After Botulinum Toxin Injection and Serial Casting

The effects of different physiotherapy programs on children with cerebral palsy who have been received botulinum toxin injection and serial casting application will be determined.

CP children who underwent botulinum toxin injection to medial gastrocnemius muscle and serial casting application in last two months will be included in the study. The effects of traditional physiotherapy and downhill backward treadmill training plus to traditional physiotherapy on muscle morphology, activity, walking, quality of life and selectivity will be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with cerebral palsy (CP) (hemiplegic-diplegic)
2. To have undergone botulinum toxin and serial casting interventions in the last 2 months
3. to be between 5-10 years old
4. Being at the level of I-II-III (ambulatory or assisted ambulatory) according to Gross Motor Function Classification System
5. To have the mental competence to understand and apply assessments and exercises

Exclusion Criteria:

1. Having undergone surgery involving the lower extremity in the last 6 months
2. Refusing to participate in the study
3. Having other accompanying neurometabolic or orthopedic disorders
DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles

Performing DNA analysis of discarded media drops from the clinical IVF cycles completed in our Center

The purpose of this research study is to investigate for the presence of DNA in the surrounding media that is remaining after human clinical IVF cycles, to have a non-invasive way of obtaining markers of embryo chromosome numeration. Media recovered from the clinical IVF laboratory is typically discarded during an IVF cycle. Genomic technologies will be used to analyze the otherwise discarded media drop for chromosome counting.

Eligibility Criteria:
Inclusion Criteria:

* Any women undergoing an In Vitro Fertilization cycle (IVF) at the Colorado Center for Reproductive Medicine that is also having Comprehensive Chromosomal Screening (CCS) of embryos

Exclusion Criteria:

-
Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation

Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years of age who had undergone liver transplantation at Hacettepe University Hospital at least one year ago were eligible for the study.

Exclusion Criteria:

* Hepatic encephalopathy
* Progressive cardiac and/or pulmonary disease
* Central nervous system pathologies
* Orthopedic problems preventing physical assessments
* Multiorgan transplantation
* Cognitive deficits
Very Severe Malaria Treated by Intravenous Artesunate

In endemic areas, Plasmodium falciparum malaria exacts a huge public health toll, causing close to half a million deaths each year. In non-endemic industrialized areas, imported malaria may develop. In France, around 5000 imported cases occured annually, including 10-15% of severe malaria.

The criteria for defining severe malaria in endemic areas are established by the World Health Organization (WHO), and have been adjusted for severe imported malaria. In France, in order to optimize management, severe imported malaria is separated into two groups: very severe malaria (VSM) and less severe malaria (LSM). Briefly VSM included coma and/or shock and/or respiratory failure and/or acidosis and/or hyperlactatemia and/or death during hospitalization.

In France, severe imported malaria is treated with intravenous artesunate. Little is known about the management of imported VSM in the ICU with intravenous artesunate.

In a French national multicentric retrospective frame, the main objective of the present study is to describe in detail: epidemiology, management, outcome and prognostic of very severe imported malaria treated with intravenous artesunate during the period 2011-2019. The second objective is to retrospectively compare two groups : VSM treated with intravenous artesunate in the ICU during 2011-2019 versus VSM treated with intravenous quinine in the ICU during 2000-2010.

See Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* More than 18 year-old at the time of inclusion AND
* Hospitalization in the ICU AND
* For severe imported malaria (Plasmodium falciparum) AND
* Very Severe Malaria episode defined during the 72 first hours as :

  * Neurological failure: Glasgow Coma Scale score\<11 or repeated convulsions and/or
  * Shock: Systolic Blood Pressure\<80 mmHg despite adequate fluid loading or need for vasoactive drugs and/or
  * Respiratory distress: Mechanical Ventilation or Non Invasive Ventilation ; or if spontaneous breathing: arterial pO2\<60 mmHg or pulse oxymetry\<92% in room air ; or Respiratory Rate\>32/min and/or
  * Acidosis: plasma bicarbonate \<15 mmol/l, or pH\<7,35 and/or
  * Hyperlactatemia \> 5 mmol/l and/or
  * Death during hospitalization for VSM

Exclusion Criteria:

* Less than 18 year-old at the time of inclusion OR
* Opposition to participate in the present study
Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis

Introduction: Ultrasound can be used to monitor muscle mass during interventional approaches in patients with liver cirrhosis.

The aim: To investigate the effect of branched-chain amino acid (BCAA) supplementation and/or muscle exercise on ultrasound-measured quadriceps muscle thickness and echo intensity, as well as on muscle strength, performance, and nutritional assessment in patients with cirrhosis.

Patients \& Methods: This is a randomized controlled study that included 220 liver cirrhosis patients with Child-Pugh B \& C classes. They were randomized into a control group comprising 55 patients who received only the standard care, and interventional groups comprising 165 patients equally distributed into three groups, they received in addition to standard care, BCAA, programmed exercise, or BCAA and programmed exercise respectively. At baseline and after 28 days, all participants were subjected to ultrasound-measured quadriceps muscle thickness and echo intensity, in addition to handgrip strength, short physical performance battery (SPPB), anthropometric measures, hematological and biochemical assessment, MELD score measurement, nutritional assessment using 7- subjective global assessment score (SGA).

This is an open, 4-arm parallel, randomized controlled trial conducted on cirrhotic patients

All eligible patients received instructions of standard care that includes standard diet and non-exercise activity thermogenesis (NEAT), then the patients were randomly assigned in an allocation ratio of approximately 1:1:1:1; group 1= control received the standard care only, and three intervention groups; group 2 received added 10 gm/day branched-chain amino acid (BCAA) (manufactured by Dulex lab company). Group 3 received added home-based exercise comprising both aerobic and resistance exercises, and finally, group 4 received added both BCAA and home-based exercise.

All patients were subjected to the following at the baseline and after 28 days:

1. thorough medical history
2. Complete clinical examination including BP, middle upper arm circumference (MUC), and body mass index (BMI) using the dry weight.
3. The nutritional status assessment using the 7-point Subjective Global Assessment (SGA) score,
4. Assessment of their physical fitness using the short physical performance battery test (SPPB) score.
5. Assessment of muscle strength using handgrip strength using a digital dynamometer (Model: 12-0286).
6. Routine labs including complete blood count (CBC), liver function, kidney function, and electrolytes, FBG
7. Calculation of Child-Pugh \& MELD scores.
8. Ultrasound assessment of quadriceps muscle thickness and echogenicity

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients with moderate and marked liver impairment

Exclusion Criteria:

* cirrhotic patients with Child-Pugh class A, patients with acute liver cell failure or malignancies, associated other end-organ failure, and vitally unstable patients.
Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.

The study will assess atacicept vs. placebo on the impact of renal function. Safety and patient reported outcomes will be clinically assessed. The clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or Female at least 18 years of age at time of signing consent
2. Must have the ability to understand and sign and date a written informed consent form
3. Diagnosis of SLE
4. Biopsy- Proven Active LN
5. Requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN
6. Subject is willing to take oral MMF for the duration of the study

Key Exclusion Criteria:

1. eGFR of ≤30 mL/min/1.73 m2.
2. Sclerosis in 50% of glomeruli on renal biopsy.
3. Evidence of rapidly progressive glomerulonephritis.
4. Currently requiring renal dialysis or expected to require dialysis during the study.
5. Serum igG \<7 g/L
6. Active infection or high infectious risk
Improving Nighttime Access to Care and Treatment (Part 2)

Children in resource-limited settings who develop illness at night are often isolated from pre-emergency care, resulting in progression to an emergency because families are forced to wait until morning to seek care. This is especially true in Haiti based on needs assessments (INACT Part 1; INACT1) surrounding access to healthcare. This study (INACT Part 2; INACT2) seeks to improve access to care by establishing a health hotline (healthline) and mobile pharmacy for families with children who become ill at nighttime. The healthline will be staffed by medical professionals and will provide phone based assessment and treatment recommendations based on standard of care practices according to Haitian and WHO guidelines. The healthline will focus on pre-emergency patients (those without danger signs as defined by WHO guidelines). Emergent patients will be advised to bypass the healthline and seek immediate care at the nearest medical facility. In the event that a non-emergent patient requires access to basic medications or fluids and is logistically accessible, the mobile pharmacy service will be offered.

The specific aims of the study are as follows: Aim I. Evaluate congruence between healthline assessment over the phone and in-person assessment of participants (patients using the healthline) 10 years of age and younger. The investigators hypothesize that in-person assessments based on WHO guidelines will be discordant with those made by the healthline because the physical aspects of the call-center assessment will be performed by an untrained parent/ guardian. The study focuses on acute diarrheal disease (ADD) and acute respiratory illness (ARI) but is not exclusive to these two chief complaints. Aim II: Identify determinants that correlate with seeking care at a medical facility over the 8-12 day follow up period after the initial call. The findings from this study will determine if a healthline model is a safe and accurate method of providing high quality access to nighttime healthcare, averting the progression of non-emergent cases to emergencies.


Eligibility Criteria:
Inclusion Criteria:

* age of patient must be 10 years or younger
* patient must reside inside the study delivery area
* consent/assent to participate

Exclusion Criteria:

* emergent illness (danger signs present)
Biorepository to Support Research in Kidney Diseases

To support advances in the understanding of pathophysiology and therapies of kidney diseases by creating a BioBank of kidney tissue, DNA, plasma, and urine from patients with kidney diseases.

A biorepository of human samples to support research to advance understanding of human kidney diseases will be created. Clinically, kidney diseases are detected by blood and urine laboratory tests. However, the underlying cause of kidney disease is often not clear on blood and urine tests. In such cases, a clinician may choose to perform a kidney biopsy to establish the diagnosis. Patients who are scheduled to undergo a kidney biopsy will be invited to participate in this proposed study.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo a clinically indicated kidney biopsy
* English or Spanish speaking

Exclusion Criteria:

* Under 18 years or age
* Known pregnancy
* Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
* Inability to provide informed consent
Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam

This Clinical and radiographic study will be designed to evaluate the temporomandibular joint condition post longstanding mouth opening during dental procedure using rubber dam. primary outcome : preoperative and postoperative assessment of interincisal distance , occlusal biting force , visual analogue scale , lateral excursion movement and Magnetic resonance imaging (MRI).

Secondary outcome: investigator will try to answer the question of what is the best duration of time could the dentist use rubber dam isolation in dental procedures without harmful effect on TMJ and its supporting structures?


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged from 18 - 40 years old of both sexes.
2. No evidence of bad habits that affect occlusion like bruxism or clenching.
3. Patient with normal occlusion.
4. Patient free of any signs and symptoms of TMD and myofascial pain.
5. Normal range of TMJ movements.
6. Normal biting force.

Exclusion Criteria:

1. Patient with systemic or local diseases that can affect TMJ like osteoarthritis, rheumatoid arthritis, or systemic lupus erythema.
2. Patient with trismus.
3. Patient with Recurrent dislocation of TMJ.
4. Swelling affects mouth opening.
5. Patient came with TMJ ankylosis.
Rinitis y Sinusitis según la Gravedad Del Asma

Based on the evidence for the "common pathway" in asthma presentation, our working hypothesis is that asthma severity and lack of control are related to the prevalence and severity of nasal and sinusal inflammatory pathology, and especially to chronic rhinosinusitis with nasal polyps.

Primary objective: To assess the prevalence and severity of rhinitis and rhinosinusitis, with or without nasal polyposis, in asthmatic patients depending on severity of their disease.

Secondary objectives:

To assess the impact of nasal and sinusal pathology on asthma control.

To correlate asthma severity to rhinitis and rhinosinusitis.

To compare the potential association between chronic rhinosinusitis, with and without nasal polyposis, and asthma severity, and to detect radiographic differences, markers of atopy, and pulmonary function.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged 18-70 years attending outpatient clinics diagnosed with asthma at least one year before. GINA/GEMA criteria will be used to diagnose asthma and to rate its severity.

Exclusion Criteria:

* Illiterate patients;
* very severe, disabling comorbidity;
* prior non-inflammatory nasosinusal disease
A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)

Our project is going to clarify the efficacy and safety of Toripalimab in lung cancer in the real world, and to evaluate the incidence of adverse events (AEs) of special interest during Toripalimab immunotherapy.

Tumor immunotherapy, as another important treatment after surgical treatment, chemoradiotherapy and targeted therapy, has achieved great success and gradually become one of the standard treatment methods for tumors. Toripalimab is the first Chinese PD-1 inhibitor approved for the treatment of nasopharyngeal carcinoma, malignant melanoma, urothelial carcinoma, esophageal squamous cell carcinoma and non-small cell lung cancer. It has been widely used in clinical practice. Several clinical studies have confirmed that it is safe and effective. In recent years, several clinical studies have reported that Toripalimab alone or in combination can improve the response rate of cancer treatment and improve survival. The results of Toripalimab research are mainly derived from rigorously designed randomized controlled trials (RCTs), and the efficacy and safety in the real world still need to be further explored. Real world studies, based on a large sample size, non-randomly select treatment measures according to the actual condition and wishes of patients, and pay attention to meaningful outcome treatment, which is closer to real clinical practice, without extrapolation difficulties, and has more clinical practical value. Therefore, it is of great significance to carry out a real-world study to investigate the differences in the efficacy and adverse reactions of Toripalimab immunotherapy in Chinese lung cancer patients in order to better guide clinical practice, which also provides research direction and data support for further prospective studies.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Cytologically or histologically confirmed lung cancer.
* Complete clinical data.
* Indications for immunotherapy with Toripalimab.

Exclusion Criteria:

* Lack of patient key data.
* Refusal or uncooperation with the study.