cyrilzakka/clinical-trials huggingface dataset:
Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain

The aim of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation alone and in combination with motor control exercises on pain and disability for patients with chronic non-specific low back pain.


Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain, defined as "pain in the low back area with or without leg pain above the knee limiting activities or daily routine which has been present for more than 3 months";
* a minimal average pain intensity of 3 out of 10 during the preceding week on a pain numerical rating scale;
* a minimal score of 10 points on the Oswestry disability index (ODI).

Exclusion Criteria:

* specific spinal pathology (fracture, tumor, radiculopathy, spinal infection, etc.);
* a history of back surgery;
* a major orthopedic, neurological, cardiovascular or psychiatric illness;
* low back pain is not the main pain complaint;
* currently using an exercise program to treat their LBP;
* presenting with any specific TMS/rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, specific medication and pregnancy;
* previous use of repetitive transcranial magnetic stimulation.
Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration

aim: to compare the accuracy of the conventional and digital impression when will be performed on implant level or abutment level in Complete digital workflow for construction of full arch implant supported screw-retained restoration.

The patient will be selected according to the following criteria:

1. Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.
2. Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.
3. Normal maxilla mandibular relationship with adequate inter-arch space, measured by tentative jaw relation.
4. Sufficient residual alveolar ridge.

Exclusion criteria include:

1. Local or general contraindications for surgical procedures.
2. Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
3. Severe inter-maxillary skeletal discrepancy or limited inter-arch space.
4. Heavy smokers.

   * For all patients, conventional complete dentures are constructed.
   * Implants installed in the edentulous maxilla and mandible in each target position guided by stereolithographic stent. A delayed loading protocol is followed in this study.
   * After osseointegration, a conventional open tray splinted impression technique will be made for each patient on the implant/abutment level.
   * Scan bodies' implant level/abutment level will be tightened for each patient, and a digital intraoral scanner will be used to scan the scan bodies for making implant level/abutment level digital impressions.

Accuracy will be evaluated as follows:

* 3D inspection software using the best-fit alignment algorithm will be utilized to calculate the 3D deviation of each impression using the root mean square (RMS) error.
* Passive fit of the framework will be evaluated at the time of insertion.

Eligibility Criteria:
Inclusion Criteria:

* Free from any systemic disease that may interfere with proper Osseointegration of implants, which will be assessed by thorough medical investigations.
* Patients having completely edentulous maxilla and mandible for at least 6 months after the last extraction.
* Normal maxilla mandibular relationship with adequate inter-arch space as verified by tentative jaw relation.
* Sufficient residual alveolar ridge.

Exclusion Criteria:

* Local or general contraindications for surgical procedures.
* Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
* Severe inter-maxillary skeletal discrepancy or limited inter-arch space.
* Heavy smokers.
Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy

To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with a preoperative high-arginine nutritional supplement. The investigator will measure patient adherence to the regimen, tolerability of the supplement and feasibility of supplementation. Secondary outcome measures will include differences in length of stay and complication rate between groups.

The purpose of this study is to investigate the use of a high-arginine protein supplement prior to surgery for patients undergoing radical cystectomy for treatment of bladder cancer. As many as 50% of patients who undergo radical cystectomy experience a postoperative complication, and poor preoperative nutritional status is known to increase the risk of complications. Preoperative use of a high-arginine protein shake has been shown to reduce the risk of postoperative complications for patients undergoing surgery for colon cancer, and this study seeks to determine whether this is also true for patients undergoing radical cystectomy for bladder cancer.

Subjects will drink four protein shakes (Nestle Impact AR) per day for 5-7 days prior to radical cystectomy. Shakes will be provided to patients free of charge. On the date of surgery, subjects will turn in a log of shake consumption. Surgery will then proceed in typical fashion, and no changes will be made to surgery or postoperative care. Clinical outcomes for the first 90 postoperative days will be collected. Patient outcomes will be compared to those of contemporary controls who do not undergo supervised nutritional supplementation. Primary study outcome is to assess safety, tolerability and adherence to supplementation regimen. Secondary outcomes include differences in complication rates and length of postoperative hospital stay between groups.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient seen at one of the aforementioned UPMC facilities who carries a diagnosis of bladder cancer and is considered a candidate for radical cystectomy for treatment.

Exclusion Criteria:

* Minors \< 18 years of age, patients not considered surgical candidates, patients who do not go on to undergo radical cystectomy. Patients with Glomerular Filtration Rate (GFR) \< 30 will also be excluded in an attempt to limit protein intake of patients with Stage IV and V Chronic Kidney Disease. Diabetic patients will be allowed to participate.
A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of approximately 27 to 35 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Baby Dvd Effects on Cortisol

The investigators will do an experiment where 9-12 month old infants are randomized to 30 minutes of block play or 30 minutes of watching a baby DVD.


Eligibility Criteria:
Inclusion Criteria:

* 9-12 months of age
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours

A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.

This is a , Phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104 in subjects with advanced and metastatic solid tumours. The study comprises of 2 phases: a dose escalation phase and a dose expansion phase. Dose escalation for AK127 will occur using the 3+3+3 model given with a fixed regimen of AK104. Dose expansion will open at the discretion of the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent
2. In Phase 1a, patients with relapsed or refractory advanced solid malignancies
3. In Phase 1b, patients must have received no more than three prior lines of systemic therapy
4. Subject must have at least one measurable lesion according to RECIST Version1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
6. Available archived or fresh tumor tissue
7. Adequate organ function.
8. For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.
9. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product.

Exclusion Criteria:

1. History of severe hypersensitivity reactions to other mAbs.
2. Subjects with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
3. Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy
4. Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment
5. Any major surgery within 4 weeks prior to the first dose of treatment
6. Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.
7. Active or prior documented inflammatory bowel disease
8. History of organ transplant.
9. History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.
10. Known active hepatitis B or C infections or history of HIV.
11. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
12. Patients with severe heart and lung dysfunction.
The Clinical Study of Novosis in Posterolateral Fusion

The purpose of this study is to evaluate the efficacy and safety of Novosis in posterolateral fusion


Eligibility Criteria:
Inclusion Criteria:

* 18\~80 aged patients needed single-level posterolateral fusion at L1\~S1
* A subject who provided written informed consent to participate in this study

Exclusion Criteria:

* Patients with BMD T-score \< -3.0
* Women who are pregnant or plan to be pregnant within study period
Exercise Capacity in Response to Enzyme Replacement Therapy in Pediatric Pompe Disease.

Our aims are to investigate the acute and long term effect of ERT on exercise capacity; comparing the effect of different ERT dosages (as prescribed by the clinician according to clinical judgment) and assessing the relationship between enzyme blood level and exercise capacity. Such evaluation may allow a more objective quantification of the response to ERT.

Pompe disease is a rare autosomal recessive metabolic myopathy caused by reduced or absence activity of the lysosomal enzyme acid alpha-glucosidase (GAA). Enzyme replacement therapy (ERT) with Myozyme has significantly improved the prospect of patients with infantile Pompe disease (IPD). Most IPD patients show clinical improvement on therapy, but deteriorate at different time points, raising the possibility that increasing drug delivery might halt the progression of the disease. Data on the effects of ERT therapy on physiological variables related to exercise tolerance is scarce.

Our aims are to investigate the acute and long term effect of ERT on exercise capacity; comparing the effect of different ERT dosages (as prescribed by the clinician according to clinical judgment) and assessing the relationship between enzyme blood level and exercise capacity. Such evaluation may allow a more objective quantification of the response to ERT.

Methods: A retrospective - prospective study evaluating pediatric patients with Pompe before and 2 days after ERT on multiple occasions and different dosing. Evaluation included cardiopulmonary exercise testing (CPET), 6 minute-walking test (6MWT), motor function test (GMFM-88) and self-collected blood samples (on a Guthrie card) for enzyme blood levels.

Eligibility Criteria:
Inclusion Criteria:

* Pompe patients \>5 years that have been on alpha-glucosidase (GAA).

Exclusion Criteria:

* Oxygen saturation \> 90% in room air without ventilatory assistance.
* Patients will be excluded if they required any invasive ventilation or if they required noninvasive ventilation while awake and upright
Bed Rest Study SBI 2023

The study will consist of three groups of subjects. Ten young male subjects (18-30 years) will lie supine for 21 days, 10 older male subjects (65+ years) will lie supine for 10 days, and a third group of 10 older male subjects (65+ years) will also lie supine for 10 days but will receive interventions (see below) to counteract the physical changes caused by supine lying. All three groups will be bedridden in the premises of Izola General Hospital. Subjects will be housed in 5-bed rooms at the hospital and will receive 24-hour medical care, proper hygiene, nutrition, passive exercise, Internet, a relaxing environment, and visits. After their stay, subjects return home but receive 21 days of care at local fitness centers. Rehabilitation consists of interval training, in which subjects perform high-intensity exercise for 4 times 5 minutes. A number of important health parameters are measured before, during, and after bed rest. Some of these measurements will be invasive (blood and muscle sampling), for which appropriate medical personnel, sterile instruments, and environment will be available. Measurements will include normal voluntary efforts (indoor cycling, various jumps, short stretches) and electrically evoked muscle contractions (electrical stimulation with single impulses). All tests are normal tests and come from normal lifestyles and routine medical examinations.


Eligibility Criteria:
Inclusion Criteria:

* age: for young arm (18-35), for old arm (65-75)
* BMI: 22 in 32 kg/m2
* appendicular muscle mass \> 7,23 kg/m2

Exclusion Criteria:

* serious acute or chronic diseases: skeletal, cancer, cardiovascular, metabolic, neuromuscular and psychiatric;
* cardiovascular disease detected on ECG examination;
* allergies to the active substances used in the study;
* problems with digestion of the active substances;
* frequent diarrhea and vomiting;
* arterial hypertension (\>140/90 mmHg);
* psychological problems;
* susceptibility to deep vein thrombosis (D-dimer \< 500 μg/L)
* poor orthostatic tolerance (frequent dizziness when changing position, especially when rising from a supine position);
* venous abnormalities that would cause difficulty in drawing blood;
* a large blood volume (more than 300 ml) in the last 3 months prior to the start of the project;
* problems with excessive consumption of alcoholic beverages;
* active smoking;
* Previous participation in any biomedical research in the last 3 months prior to the start of this study;
* a communicable disease before the start of the project;
* any ferromagnetic implant.
Structural and Functional Characterization of Rare Ocular Diseases

Rare ocular diseases (ROD) are a heterogeneous group of ocular diseases that affect very few people and, generally, for which no tretament is available. An important subgroup of these diseases are inherited retinal degenerations. In this study we focus on understanding the natural history of different ROD that affect the posterior segment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older with a diagnosis of a ROD affecting the posterior segment
* Patients able to undergo all required ophthalmic exams
* Patients able and willing to sign an informed consent

Exclusion Criteria:

* Patients with other concomitant posterior segment disorders
* Patients taking drugs known to affect the retina and/or optic nerve
* Patients that underwent an intraocular surgery (aside from phacoemulsification with intraocular lens implantation), corneal or glaucoma surgery
* Patients who have participated in the past 12 months or that are currently participating in clinical trials for an ocular disease
Consenso2_F1 Delphi Consensus Study on Post-graduate Medical Education Success and Failure and Its Influencing Factors

The objective of this study is to generate expert consensus statements on the definitions of success and failure and its influencing factors in Post-graduate medical education.

A study will be performed using a e-Delphi process with Portuguese expert panel to generate recommendation statements related to the definitions of success and failure in Post-graduate medical education and its influencing factors and to determine the level of agreement for each statement from the panel as a whole. The following topics will be covered:

1. Success in Post-graduate medical education: definition, influencing factors
2. Failure in Post-graduate medical education: definition, influencing factors
3. Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met (75% agreement).

Part 1: planning and evidence review

* Series of planning sessions with study investigators
* Literature is reviewed/summarized
* Initial statements will be developed based on Round 1 results. Round 1 will be composed of 4 open-ended questions

Part 2: Survey to achieve consensus

* Survey, based on the initial statements developed on Round 1 results
* At least 2 additional rounds of review (remote rounds using an online platform) will be held to achieve consensus on each topic of interest and finalize consensus statements

Eligibility Criteria:
Inclusion Criteria:

* residency programs directors,
* members of the medical residents representing committee,
* members of patients representing associations,
* members of health institutions management teams,
* members of Portuguese Medical Association,
* authors of relevant scientific articles on medical education

Exclusion Criteria:

• Panelists who are not able to commit to all rounds of the modified Delphi process will be excluded.
Effect of Diode Laser Activated Irrigation Versus Ultrasonic on Post-Operative Pain in Single Visit of Necrotic Teeth

the investigator intended to study the effect of laser versus ultrasonic in activation of irrigation in post operative pain of patients have a symptomatic necrotic teeth

the investigator will choose from patients entering clinic of endodontics in faculty of oral and dental medicine Cairo university who are eligible to the criteria.

After the patients is found eligible,the patients will be randomly assigned to either the control (ultrasonic activated irrigation )or to the intervention ( diode laser activated irrigation) treatment done in both in single visit.

At the end of treatment, patients will be asked to record post operative pain by NRS .

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic necrotic single rooted single canal teeth with or without chronic periradicular lesion.
* Teeth with mature root
* Teeth without calcified root canals
* Teeth without root caries
* Teeth without internal or external root resorption
* Teeth with no sign of crack formation
* Teeth without anatomic abnormalities

Exclusion Criteria:

* Pregnant or lactating females
* Teeth with vital pulp
* Non- restorable teeth
* Medically compromised patients
* Patients with facial swelling or acute infection.
* Previously endodontically treated teeth
* periodontally affected teeth
The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children

To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride ( 256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold sores ) and/or varicella / zoster virus infections ( chicken pox / shingles ).

Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.

Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.

In the first cohort, patients with stable herpes simplex virus receive valacyclovir hydrochloride at 1 of 2 doses, depending on body surface area (BSA), for 10 days. If acceptable safety is seen at this dose level, a second cohort of patients with stable herpes simplex virus receive a higher dose, depending on BSA, for 10 days. A third cohort of patients with varicella or zoster receive a selected dose based on results from the previous cohorts.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretrovirals.
* PCP prophylaxis.
* IVIG, G-CSF, and erythropoietin.

Concurrent Treatment:

Allowed:

* Transfusions.

Patients must have:

* Localized mucocutaneous herpes simplex OR undisseminated varicella or zoster.
* HIV positive. NOTE: Varicella patients must NOT have AIDS.
* CD4 count \>= 100 cells/mm3 (herpes simplex or zoster patients) OR \>= 250 cells/mm3 (varicella patients).
* BSA \> 0.6 m2.
* Ability to swallow solid dosage formulations.

Prior Medication:

Allowed:

* Prior VZV immune globulin and/or IVIG.
* Antiretrovirals if at a stable dose for at least 14 days.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinical evidence of pneumonitis.
* Severe abdominal pain or back pain.
* Encephalopathy.
* Hemorrhagic varicella.
* Zoster involving ophthalmic branch of trigeminal nerve.
* Severe gastrointestinal disorder.

Concurrent Medication:

Excluded:

* Agents with potential activity against HSV or VZV, such as acyclovir, famciclovir, ganciclovir, foscarnet, and sorivudine.
* Probenecid.
* Aspartamine within 48 hours prior to pharmacokinetic samplings.

Patients with the following prior conditions are excluded:

* Grade 2 creatinine value within the past 30 days.
* Grade 3 hematologic or hepatic values within the past 30 days.
* Prior hypersensitivity and/or allergic reaction to acyclovir.
* Grade 3 or 4 mental status changes within the past 30 days.

Prior Medication:

Excluded:

* Acyclovir within 1 week prior to study entry.
* Steroids within 4 weeks prior to onset of varicella lesions.