cyrilzakka/clinical-trials huggingface dataset:
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism.

The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.


Eligibility Criteria:
Inclusion Criteria:

* Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer, including chemotherapy for hematologic neoplasms, at least 2 months and not more than 2 years prior to enrolling,
* Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
* Be able to speak and/or read and write in English,
* Be at least 18 years old,
* Own a smartphone,
* Be willing and able to adhere to study procedures, including use of a smartphone app, and
* Be able to provide informed consent.

Exclusion Criteria:

* Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week,
* Be underweight, as defined as a body mass index ≤18.5 kg/m2,
* Have surgery planned during the study duration,
* Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder),
* Be taking insulin, or
* Be on enteral or parenteral nutrition.
The Impact of Phase I Cardiac Rehabilitation on the Prognosis of AMI Patients After PCI

Previous research has confirmed that patients undergoing percutaneous coronary intervention (PCI) can benefit from cardiac rehabilitation programs. However, there is a paucity of studies on Phase I cardiac rehabilitation commenced within three days following PCI in patients with acute myocardial infarction (AMI). Consequently, the objective of the study is to demonstrate whether Phase I cardiac rehabilitation can improve the prognosis at 12 months when compared with the control group. The primary endpoint is the Seattle Angina Questionnaire (SAQ) score at 12 months for the patients. The principal hypothesis of the study is that Phase I cardiac rehabilitation will improve the long-term prognosis for AMI patients at 12 months after PCI.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with AMI (including STEMI and NSTEMI) who were treated in the CCU (Coronary Care Unit) for more than 12 hours after emergency PCI;
2. Patients who are expected to meet the discharge criteria without the need for repeat PCI during the current hospital stay after PCI;
3. No chest pain episodes within 8 hours, with no recurrence of myocardial infarction; remained hemodynamically stable;
4. No further increase in serum levels of cardiac biomarkers such as Creatine Kinase -MB (CK-MB) and cardiac troponins (cTn).

Exclusion Criteria:

1. Patients with Killip class III or higher, or symptoms and signs of acute pulmonary edema and respiratory distress;
2. Malignant arrhythmias that cause hemodynamic instability and potentially life-threatening conditions;
3. Mechanical lesions such as ventricular wall rupture, valve or tendon rupture;
4. Patients who have not yet been weaned off ECMO, IABP, temporary pacemakers, CRRT;
5. Patients with liver or kidney dysfunction (transaminase exceeded three times the upper limit of normal; EGFR\<30 ml/(min·1.73m\^2)) or advanced malignant tumors;
6. Patients who cannot undergo exercise rehabilitation due to orthopedic or psychiatric diseases;
7. Patients with language impairment;
8. Patients currently undergoing systematic training or participating in other clinical trials without reaching the primary endpoint collection time;
9. Researchers believe that patients are not suitable for participation in this study or have not obtained an informed consent form.
CD vs IOD Opposing Mandibular IOD : Bone Height Changes of the Premaxilla

The goal of this clinical trial is to evaluate bone resorption of the anterior region of maxillary arch. The main questions it aims to answer are:

Does implants assisting maxillary complete denture enhance stability, retention and mastication of the patient ?

Does implants assisting maxillary complete denture reduce bone resorption in the anterior region of maxilla ?

Participants will:

* receive 2 implants with attachments assisting their maxillary complete denture
* Visit the clinic once every 6 months for checkups and tests

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation.

The trial will include A total of twenty male adult patients unsatisfied with their maxillary complete denture seeking to enhance their mastication and esthetics. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.

each patient will receive 2 implants with attachments to assist their maxillary complete denture then follow up every 6 months for checkups.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation

Eligibility Criteria:
Inclusion Criteria:

1. General good health without any systemic diseases affecting bone resorption such as uncontrolled diabetes or osteoporosis. This was confirmed through taking medical history and clinical examination by a physician.
2. Having angel's class I maxillo-mandibular relationships.
3. Presence of sufficient bone quality and quantity in the anterior region of maxilla and mandible which allow inserting implants of at least 3.75 mm diameter and 10 mm length. This was verified by Preoperative low dose Cone Beam (C.T) d) Presence of sufficient restorative space (a minimum of 15 mm must be available from the mucosa covering the crest of the residual ridge to the proposed occlusal plane), this was confirmed by tentative jaw relation.

(e) Having maladaptive maxillary conventional complete denture.

Exclusion Criteria:

1. Uncontrolled systemic diseases such as: uncontrolled hypertension, or uncontrolled cardiovascular disease
2. metabolic disorders such as diabetes mellitus
3. Patients with compromised immune systems as (Long term immunosuppressant and corticosteroid drug
4. TMJ dis orders and neuromuscular diseases
5. Patient with abnormal habits as clenching and bruxism, Smoking patient, Uncooperative patients.
Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate ICP-488.Efficacy, safety, PK, and PD characteristics in Chinese adults with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in this study and have signed informed consent.
2. Male or female subjects between the ages of 18 and 70 (including the threshold) at the time of signing the ICF.
3. History of plaque psoriasis ≥6 months at baseline.
4. Subjects need to receive systemic therapy and/or phototherapy.
5. The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores

Exclusion Criteria:

1. The diagnosis was non-plaque psoriasis.
2. Presence of infection or immune-related disease.
3. Subjects with a history of TB or at risk for TB.
4. Received related treatment within the time window specified in the protocol.
5. An interval of less than 5 half-lives or 28 days (if any available halflife data) from the last dose of a strong CYP1A2 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food with strong CYP1A2 inhibitory or inductive effect during study participation.
6. The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol.
7. Pregnant or lactating women, or women who plan to become pregnant during study participation.
8. A history of severe drug allergies.
9. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
Effect of PDRN in Post-operative Scars

The investigators aimed to evaluate the efficacy of PDRN administration in early wound healing phase on prevention of post-operative scars after open thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

• Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital

Exclusion Criteria:

* age younger than 20 years or older than 60 years
* history of keloid development
* requirement for modified radical neck dissection
* previous neck surgery
* current pregnancy or breast feeding
* allergy to PDRN
* taking medications that may affect inflammation and would healing such as isotretinoin, anti-cancer drugs, high dose corticosteroids, and anticoagulants
* uncontrolled medical diseases
Resistance Exercise and Peer Support with Bands/balls and Digital Support Among Women with Polycystic Ovary Syndrome

The purpose of this one arm pilot was to assess the feasibility and acceptability of REPS w/BANDS and evaluate for signals of improvement for depressive symptoms, anthropometrics, and muscular endurance. Participants completed a 12-week personalized in-home resistance exercise program that was delivered in real-time via a smart home video device along with a buddy system for peer support.

Research findings reveal that women with polycystic ovary syndrome (PCOS) report low exercise motivation due to PCOS stigma-related stress and lack of social connection, thus inhibiting exercise in public and group settings. The purpose of this study was to implement and assess the feasibility and acceptability of an in-home personalized resistance exercise (RE) program delivered in real time by a smart home video device (SHVD) with peer support provided by a buddy system. This theory-informed, one-arm proof-of-concept study provided participants (n=10) with an SHVD, exercise equipment (exercise bands, stability ball), and 2 supervised RE sessions per week for 12 weeks via the SHVD's video feature and incorporated strategies from self-determination theory to meet the psychological needs of autonomy, competence, and relatedness. Participants were randomly paired with a buddy. Feasibility, acceptability, depressive symptoms, anthropometrics, and muscular endurance were measured using surveys, fitness testing, and interviews. Quantitative data were calculated using t-tests. Qualitative data were analyzed via thematic analysis.

Eligibility Criteria:
Inclusion Criteria:

* an age of 18 or older
* a confirmed PCOS diagnosis by a healthcare provider
* physical activity readiness as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
* residence within driving distance of the main university campus.

Exclusion Criteria:

* cardiorespiratory disease (e.g., congestive heart failure)
* hypertension
* orthopedic injury (e.g., herniated disc)
* pregnancy.
Telmisartan Tab Hypertension

To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk

Study Design:

Eligibility Criteria:
Inclusion criteria:

Hypertensive patients with BP. 140/90mmHgand high and very high cardiovascular risk according to the ESH/ESC Guidelines 2007 and in whom the prescriber has taken the decision to start treatment with telmisartan 40 or 80 mg, with or without HCTZ 12.5 mg or 25 mg, in the usual way and in line with the SmPC and reimbursement criteria

Exclusion criteria:

Contra-indications as in the Summary of Product Characteristics
Fuchs' Torsional Phaco Study

The primary objective is to compare the effect of torsional phacoemulsification and longitudinal phacoemulsification on central and peripheral corneal thickness/volume after cataract surgery in patients with Fuchs' endothelial dystrophy.

Fuchs' endothelial dystrophy is a progressive, bilateral disease of the corneal endothelium, which eventually leads to corneal decompensation. In the early stage, some patients develop visually significant cataract. During cataract surgery ultrasound (US) power is used to emulsify the lens, which leads to endothelial cell loss and tissue damage. The reduction of US power has become the primary surgical goal in cataract surgery, which is especially important in patients with Fuchs' endothelial dystrophy to limit endothelial cell loss.

In 2006, Alcon Surgical introduced a torsional mode in its phacoemulsification system (Infiniti Vision System). It includes a handpiece that produces rotary oscillations of the phacoemulsification tip and is suggested to reduce the amount of US power required to remove the cataractous nucleus, because it does not produce repulsion and breaks up the cataract by shearing and not by the conventional jackhammer effect. This reduction in US power, could lead to less endothelial cell damage than the conventional (longitudinal) mode, which is reported recently for patients with hard cataract. It is important to investigate patients with Fuchs' endothelial dystrophy, because patients with a compromised endothelial cell layer will benefit the most from less endothelial cell damage. Consequently, this lower level of endothelial damage may postpone the date of keratoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Fuchs' endothelial dystrophy (all stages) and planning to undergo cataract surgery due to visually significant cataract
* Patients should be 40 years of age or older

Exclusion Criteria:

* Patients with Fuchs' dystrophy with a history of previous corneal or intraocular surgery
* Patients with a planned combined surgical procedure
* Patients who have other vision-affecting disorders than Fuchs' endothelial dystrophy
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation

The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

* In sinus rhythm at treatment initiation
* Experienced symptomatic AF episodes
* Left ventricular ejection fraction of at least 40%
* Females of child bearing potential must be using reliable method of contraception

Exclusion Criteria:

* Intolerance and/or failure of previous therapy with flecainide immediate release
* Currently receiving \>200mg/day flecainide immediate release
* Severe symptoms during episodes of arrhythmia
* History of other cardiac conditions/abnormalities
* Heart surgery within the last 2 months
* Renal failure
* Pregnant or lactating females
* Significant extra cardiac or systemic disease
* Abnormal electrolyte levels
* Receiving defined cardiac and/or other treatments
Effects of Hipopressive Exercises in Nonspecific Low Back Pain

Introduction Non-specific low back pain is very prevalent in our society. Different effective physiotherapy treatments have been performed in the reduction of pain and improvement of quality of life, however there are few studies that exist on the effectiveness of these treatments in protocol format based on manual therapy. On the other hand, there are no studies that implement a protocol of therapeutic exercises called abdominal hypopressives.

The aim of the study is to study the effect of a manual therapy protocol on non-specific low back pain and the implementation of hypopressive exercises in different areas such as disability, pain, flexibility and quality of life.

Material and methods

Participants The sample will consist of subjects with non-specific low back pain. Inclusion criteria

-Participants with nonspecific lumbar pain of at least 4 pain crises a month with recurrent low back pain.

Exclusion criteria

* Light acute.
* Lumbalgia after trauma.
* Presenting sciatica or musculoskeletal disorders or injuries within three months prior to the study.
* Contraindication of one of the two treatments.
* Participate in this period of no functional recovery program or physiotherapy treatment.

Study design A randomized clinical trial will be conducted. The sample will be divided into 2 groups: Group 1 will receive a manual therapy protocol that has previously shown its effectiveness in non-specific low back pain being 1 session a week, while group 2 will receive a protocol of hypopressive therapeutic exercises.

Evaluations

At the beginning of the study, a clinical interview will be carried out and, in addition, 3 evaluations will be carried out: at the beginning, at the end of the treatment and one follow-up per month. The investigators will use the following evaluation tools:

* Pain, through the Visual Analog Scale.
* Oswestry Low Back Pain Disability Scale.
* SF-36 quality of life scale.
* Visual Analog Scale.
* Algometry of spinous processes and lumbar muscles.
* Lumbar flexion with inclinometer and fingers test - floor.


Eligibility Criteria:
Inclusion Criteria:

* Man between 18 and 40 years old
* Recurrent episodes of low back pain at least 4 times a month
* At least 3 months of evolution
* Non-specific low back pain
* Not having undergone surgery

Exclusion Criteria:

* Acute low back pain
* Lumbalgia operated surgically
* Low back pain after traumatism
* Episodes of sciatica
* Contraindication to any of the treatments
* Attend, during the study period, rehabilitation programs
* Serious injuries in the 3 months prior to the study
* Root pain
* Any breach of the inclusion criteria
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery

The purpose of this study is to evaluate the penetration of levofloxacin and dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.

In most cases, postoperative care after cataract surgery consists of antiinflammatory and antibacterial drug therapy. The use of an ophthalmic solution containing the combination of a steroid and an antibiotic is routinely used in clinical practice; however, treatment duration could favour the emergence of antibiotic resistance. The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time (one week) is therefore of considerable interest.

The aim of this study is to measure the concentrations of levofloxacin and dexamethasone in the aqueous humour after topical application of the combined ophthalmic solution and its single components.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Male or female patients, aged ≥40 years
3. Patient undergoing phacoemulsification
4. Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry
5. Corneal integrity confirmed by means of fluorescein test
6. Adequate pupil dilation assessed at screening
7. Female patients of childbearing potential must have a negative pregnancy test
8. Ability to fully understand all study procedures

Exclusion Criteria:

1. Corneal epithelium integrity not confirmed by fluorescein test
2. History of corneal disease or dystrophy
3. History of ocular trauma with corneal damage
4. History of acute ocular inflammation (including uveitis) in the 6 months prior to screening
5. Previous ocular surgery (including laser treatment)
6. Glaucoma
7. Treatment with an ophthalmic investigational drug in the 3 months prior to screening
8. Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic within 10 minutes before start of surgery
9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery
10. Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery
11. Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone
12. Pregnant or lactating women
13. Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, or who have previously participated in this trial
Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions

The goal of this observational study is to evaluate the combined single-step approach with biomaterials and mesenchymal stem/stromal cells in the treatment of knee articular surface lesions. The clinical analysis of the treatment outcomes, regarding postoperative improvements and safety, is going to be accompanied with laboratory analysis of the intraoperatively applied cellular products.

The main hypothesis are: (1) such combined single-step procedure significantly improves patients' functioning and quality of life; (2) this therapeutic approach is safe; (3) cellular parameters of the applied filtered bone marrow aspirate (fBMA) impact treatment outcomes, among other potential predictors.

Researchers will compare subjective (questionnaire) and objective (clinical examination) status of patients before and after the operation, record any potential complications and perform regression analysis to assess the influence of potential predictors on postoperative improvements.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* patients treated with combined single-step procedure (scaffold and fBMA) for knee articular surface lesions, between January 2013 and December 2020
* symptomatic knee articular surface lesions (International cartilage repair society (ICRS) grades 3-4, size ≥ 1.5 cm2) unresponsive to conservative treatment,
* only mild concomitant osteoarthritis (Kellgren-Lawrence grades 1-2)

Exclusion Criteria:

* patients that refuse to participate in the study
* non responders to the invitation to answer PROMs at the follow-up
* associated medical conditions (inflammatory, metabolic, neoplastic, etc.) that could directly handicap the musculoskeletal system or indirectly impact the quality of life