cyrilzakka/clinical-trials huggingface dataset:
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction

Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and/or soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and/or feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL).

Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.

The aim of this study is to evaluate the efficacy of PBMT in the management of HFS and HFSR in patients with cancer treated with chemotherapy or TKIs up to 2 weeks post-PBMT.

Primary objective: The study seeks primarily to determine the effectiveness of PBMT in reducing the severity of HFS and HFSR in patients with cancer of different etiology undergoing chemotherapy or TKIs, diagnosed with HFS or HFSR (grade 1-3).

Secondary objective 1 : HFS/HFSR-related symptoms

A secondary aim of this study is to evaluate if PBMT and can reduce the HFS/HSFR-related symptoms during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 2: Quality of life

A secondary aim of this study is to evaluate if PBMT can improve the patients' QoL during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 3: Patient satisfaction

A secondary aim of this study is to evaluate if patients are satisfied with PBMT as a treatment for HFS and HFSR during the treatment sessions and up to 2 weeks post-PBMT

Secondary Objective 4: PBM safety

A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer of different aetiologies
* Undergoing chemotherapy or targeted therapy (TKIs)
* Diagnosed with HFS-HFSR grade 1, 2 or 3 (National Cancer Institute - Common Terminology Criteria for Adverse Events, NCI-CTCAE v5)
* Age ≥ 18 years
* Able to comply to the study protocol
* Able to sign written informed consent

Exclusion Criteria:

* Pre-existing skin rash, ulceration or open wound in the treatment area (hand, foot)
* Known allergy to polyurethane
* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Comparing Mescaline Sodium Enteric-coated Tablets vs Morte-mescaline in the Treatment of Adult Lupus Nephritis

The goal of this prospective, multicenter,real-world study is to To evaluate the efficacy and safety of mescaline sodium enteric-coated tablets versus morte-mescaline in the treatment of adult patients with lupus nephritis under real-life medical conditions.

The main question it aims to answer are: Is the efficacy of mescaline sodium enteric-coated tablets in the treatment of adult patients with lupus nephritis not inferior to morti-mescaline？ Participants will receive induction and maintenance treatment with mescaline sodium enteric-coated tablets and morte-mescaline.Then participants will be followed up at 60, 180, 270 and 540 days of treatment to assess the efficacy and safety of mescaline sodium enteric-coated tablets compared to morte-mescaline.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18-70 years; 2. Meet the 2019 SLE classification criteria established by EULAR/ACR; 3. Have any of the following clinical and laboratory abnormalities: 1) proteinuria \>0.5 g/24h, or urine protein ++++ on random urinalysis, or urine protein/creatinine ratio EE \>500 mg/g (50 mg/mmol); 2) cellular tubularity including erythrocyte tubularity, hemoglobin tubularity, granular tubularity, tubular tubularity, or mixed tubularity; 3) active urinary sediment (except 3) active urine sediment (except urinary tract infection, urine leukocytes \>5/HPF, urine red blood cells \>5/HPF), or erythrocyte tubular, or leukocyte tubular; 4. 24h urine protein quantification ≥ 1.0 g; 5. Require long-term treatment with MPA-type drugs (mescaline sodium enteric-coated tablets or morte-mescaline); 6. Singed the informed consent.

Exclusion Criteria:

* 1. Patients treated with immunosuppressive agents (e.g. CTX, MPA, CNI, etc.) within 30 days 2. Patients with co-morbid severe CNS infections 3. Neutrophil counts \<1×103/µl; 4. Glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 ; 5. Glutamic aminotransferase (ALT), glutamic oxalacetic aminotransferase (AST) or total bilirubin \> 1.5 x upper limit of normal (ULN); 6. Pregnant or lactating women 7. Presence of other major diseases such as tumors, HIV viral infections, systemic bacterial/fungal/viral infections; 8. Presence of contraindications to glucocorticoids and investigational drugs 9. Any condition that, in the judgment of the investigator, is unstable or may jeopardize the safety of the subject and his or her compliance with the study.
Home Usability of a Nasal Lavage System in Children

This study evaluates labeling comprehension, ease of use and effectiveness of a new device for nasal and sinus irrigation and/or aspiration. The device is currently cleared for professional use and home use with a prescription. This is a usability study to demonstrate that this device is appropriate for home use.

Nasal congestion is an important complication of viral upper respiratory infections in young children. It can lead to poor eating, sleeping and breathing. Recently, the FDA recommended against using over-the-counter cold remedies in young children because of inefficacy and occasional dangerous side effects. A commonly recommended non-drug solution for nasal congestion is nasal suctioning. This can be effective but currently available methods have been found to be awkward, uncomfortable and ineffective.

The studied device has potential for making nasal suctioning easy to perform in the home setting, especially in young children. It is already FDA cleared for professional use and this study was developed to demonstrate that it is appropriate for the home as well. This would be significant as it would allow parents a strategy of clearing their child's nose without drugs.

The device is automatic and handheld that can irrigate and/or aspirate the nasal cavity with hospital-grade suction. The handle houses a pump that can achieve air flows known to be effective for infant nasal suctioning in the hospital. A disposable wash-head is placed on top. It has an irrigation chamber with 0.9% saline and another chamber for collecting the aspirated nasal contents. The unit operates from a single bi-functional button.

Several key safety features have been built in such as: a tip that is shaped to maximize the seal but prevent intrusion into the nose; an irrigation function that delivers an optimal volume but prevents flooding the nasal cavity; and a pump that can deliver suction known to be effective in the hospital but whose safety valve does not allow it to rise above dangerous levels.

Participants were parents of children who have nasal congestion for whom nasal suctioning is traditionally recommended. They were asked to review the instruction manual of the device, and then use it on their children.

The primary outcome was proper use of device that was precisely defined. Additionally, subjective efficacy of mucus removal, evidence of adverse events and understanding of the device's user manual were also measured.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children less than 6 years of age who were suffering from nasal congestion for which nasal suctioning and salt water irrigation/drops are prescribed.

Exclusion Criteria:

* Parents of children in marked respiratory distress or who maxillofacial malformations not conducive to nasal suctioning.
* Additionally, parents of children with recurrent nose bleeds, bleeding disorders or irritated peri-nasal skin were excluded.
Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure

The objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received salvage protease-inhibitor (PI) based regimens.


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* documented HIV infection
* previously failed to NNRTI-based regimens
* no history of failing PI-based regimens
* receiving ritonavir-boosted PI + OBRs(such as NRITs, etravirine, raltegravir)
* having HIV-1 RNA \<50 copies/ml for at least prior 6 months

Exclusion Criteria:

* Pregnant or breastfeeding woman
* HBV co-infection that had to treated with TDF, FTC or 3TC
* had to received medications known to have potential significant drug interaction with LPV/r
* life expectancy less than 6 months
* serious systemic diseases such as liver cirrhosis Child-Pugh B/C, ESRD, malignancy
* hemoglobin \<8 g/dl, platelet \<50,000/mm3, AST or ALT \>3 ULN, estimated creatinine clearance \<50 mL/min
Copeptin in COVID-19

This study aimed to investigate the change in serum level of copeptin, a neuroendocrine biomarker, in differentiation between mild-moderate and severe COVID-19 cases on admission time and to find its diagnostic potential.

This prospective study enrolled 160 individuals with confirmed COVID-19 infection using PCR. They were recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt, which was specifically designated for the isolation of SARS-CoV-2 positive patients. According to the Egyptian ministry of health and population's (MOHP) recommendations, patients were divided into 80 mild-moderate COVID-19 patients and 80 severe COVID-19 patients. Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent), while severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent). All participants or their corresponding companions signed a free informed consent form. The study was approved by the research ethics committee of Al-Azhar University's Faculty of Medicine (Girls), Cairo, Egypt, with approval number (202106884), and adhered to the Helsinki Declaration's precepts. Pregnancy, COVID-19 patients with morbid obesity, cancer, or autoimmune disease, and those who took immunomodulators or initiated the COVID-19 treatment programme were excluded. Additionally, patients having a history of recurrent COVID-19 infection were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

Adult patients \> 18 years with the positive result of real-time reverse transcriptase-polymerase chain reaction assay (RT-PCR) for SARS-CoV-2 RNA.

Severity stratification is based on the guidance of the Egyptian MOH protocol.

Exclusion Criteria:

Pregnant COVID-19 patients. COVID-19 patients with morbid obesity, malignancy, autoimmune diseases and those who received immunomodulators or began COVID-19 treatment protocol.

Also, patients with a history of recurrent COVID-19 will be excluded.
Efficacy of an Autobiographical Memory Specificity and Savoring Training for the Reduction of Depressive Symptomatology

The effect of autobiographical memory specificity and savoring training on memory specificity, positive affect regulation, well-being and depression symptomatology

The general objective of this study is to analyze the efficacy of an online-delivered Autobiographical Memory Specificity and SavoringTraining to increase the specificity of positive autobiographical memories, positive affect regulation strategies, well-being and to reduce depression symptomatology. It will be tested in two conditions (training group vs. control group) with low-to-moderate depressive symptomatology. It is hypothesized that the training group (over control group) will increase the specificity and positive affect regulation of autobiographical memories, and this will lead to a reduction of depressive symptomatology and increase of well-being.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55 (following Serrano et al., 2007 recommendations)
* Deficit in memory specificity: scores on Autobiographical Memory Test (AMT) \< (or equal) 70%
* Diagnosis of mild to moderate depression: scores on Patient Health Questionnaire (PHQ9) between 5 to 14

Exclusion Criteria:

* being currently under psychological treatment
* present any medical illness or physical, psychological and/or cognitive incapacity that could impede the participation
* Not having the necessary technological means, i.e. access to a mobile phone with internet connection.
Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses

The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.

This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to understand and sign an Informed Consent;
* Willing and able to attend post-operative examinations as per protocol schedule;
* Diagnosis of bilateral, age-related cataracts;
* Planned cataract removal via phacoemulsification with implantation of an IOL;
* Available to undergo second eye surgery within 6 weeks of the first eye surgery;
* Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
* No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
* Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
* Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery and/or reshaping;
* Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
* Pregnant, lactating, or planning pregnancy during the course of study;
* Other protocol-defined exclusion criteria may apply.
Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population

This is a double blind, randomised, placebo-controlled, parallel-group trial to evaluate the effect of Maolactin FMR supplementation on post exercise inflammation, exercise recovery and muscle fatigue and pain in an otherwise healthy population of adults 18-65 years old over 10 weeks with 8 weeks of supplementation.

This is PART A of the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 years old
* Generally healthy
* BMI 19.0 - 29.9 kg/m2
* Able to provide informed consent
* Generally active, low to moderately trained (with a minimum of 1 resistance exercise sessions per week)
* Agree not to change current diet and/or exercise frequency or intensity during study period
* Agree to not participate in another clinical trial while enrolled in this trial

Exclusion Criteria:

* Undertaking high intensity exercise training and or undertaking more than 3 days of resistance training per week.
* Serious illness(1) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Unstable illness(2) e.g., diabetes and thyroid gland dysfunction
* Unstable intake of any medication or supplement(3)
* Acute injuries on reporting area
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
* Receiving medications known to affect inflammation such as steroids
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>21 alcoholic drinks per week)
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

  1. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
  2. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
  3. An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser

As atrophic striae are common dermatological conditions. Various therapeutic modalities have been employed in the treatment of striae distensae, mainly in striae rubra. There are few studies that include the treatment of striae alba.

The non-ablative fractionated laser and, more recently, microneedling are two distinct treatments, but they are widely used in dermatologist practice.

The present randomized clinical trial is aimed at evaluating and evaluating the response of microneedle and fractional non-ablative laser Nd-yap 1340 in the treatment of abdominal striae alba.

Twenty patients will be treated at the dermatologic clinic of the Hospital de Clínicas de Porto Alegre (HCPA). Each patient will be treated with laser and microneedle at the same time, being applied a therapeutic procedure in each part of the abdomen (divided lengthwise and in equal parts). Each part of the abdomen will be randomized for the treatment of laser or microneedling with the help of the Excel 2013 program. The investigator responsible for procedures and patients are the only ones with unblinded assessment in relation to the side of each treatment. There will be 5 sessions with monthly intervals of the proposed treatments. The ND-yap 1340-nm laser will be used, and in the other segment of the abdomen, the dermaroller 2.5 mm was applied. Photographic records of patients will be performed at pre-treatment and 1 month after the third and fifth sessions. The questionnaires will be applied to assess the quality of life in dermatology DLQI (Dermatology Life Quality Index). Two independent and blind evaluators for the type of treatment will apply in the Global Aesthetic Scale (GAIS) in the evaluation of photographic records. Cutaneous biopsies for histopathological evaluation will be performed with a punch 3 mm of each part of the abdomen at pretreatment. Two experienced pathologists will evaluate the measurements of the epidermis and the collagen and elastic fibers of the skin.

Eligibility Criteria:
Inclusion Criteria:

* female patients,
* age 18 and over;
* presenting with abdominal striae rubra diagnosed after clinical examination;
* patients with weight stability in the last four months;
* patients with Fitzpatrick III or IV phototype.

Exclusion Criteria:

* pregnant women;
* childbirth for less than 12 months;
* history of keloid scars;
* presence of localized or systemic infection;
* presence of immunosuppression;
* use of photosensitizing medications;
* use of systemic steroids;
* use of oral isotretinoin in the last 12 months;
* history of diseases of collagen or elastic fibers;
* hypersensitivity to infiltrative or topical anesthetics;
* patients who have been treated for striae distensae in the last year;
* presence of sun exposure during the study.
The Effect of Meditation Applied to Elderly Individulas on Sleep Quality and Psychological Well- Being

It is planned as a randomized controlled experimental study to examine the effect of theta healing meditation technique on sleep quality and psychological well- being of elderly individuals.

To evaluate the effect of theta healing meditation technique on sleep quality and psychological well- being in individuals over the age of 65, a study will be conducted with a total of 34 individuals consisting of a study and control group. Analysis of the research sample size was made using the G power 3.1.9.6 program. In the study, individuals who can communicate in Turkish, have received written and verbal permission to participate in the research, are over 65 years old, have a score of 24 or more on the Standardized Mini Mental Test (SMMT), have no preception disorder, and have no hearing problems will be included in the study. İndividuals who meet the research criteria for members of retirement homes will be included in the research. Sample selection will be completed in accordance with the study' s inclusion, axclusion criteria, followed by randomization. Individuals will be informed about the purpose of the research and the the research process, and the patient individuals will be given the ''Informed Voluntary Consent Form'' and ''Patient Introduction Form'', ''Pittsburg Sleep Quality Scale'' and ''Psychological Well- Being Scale (PERMA)'' as pre- tests, face to face, will be filled.Theta healing technique and meditation, visualization and thinking practice will be applied to the elderly individuals in the study group face to face under the guidance of the researcher for 20 minutes, 2 days a week, for 4 weeks.There will be no intervention in the control group for a 4 week period. After the 4- week theta healing meditation application is completed with the study group,''Pittsburg Sleep Quality Scale'' and ''Psychological Well- Being Scale (PERMA)'' scales will be applied to the study and control groups as a final test. The research will be competed by statistical analysis and reporting of the data obtained from the research.

Eligibility Criteria:
Inclusion Criteria:

* Written and verbal permission was obtained to participate in the research, Able to communicate in Turkish, Those aged 65 and over, Those who signed the informed consent form to participate in the research, Having a Standardized Mini Mental Test (SMMT) score of 24 points and above, No perception disorder, Without psychological medical diagnoses, Those without hearing problems will be included.

Exclusion Criteria:

* Standarzide Mini Mental Test (SMMT) score below 24 points, Having a perception disorder, Those with psychological medical diagnoses, Having hearing problems, Cannot communicate in Turkish, Those who have any health problems during the application process, Those who cannot continue the research for any reason, Those who want to leave the research with their own consent will not be included in the research.