cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of the TSV Dental Implant System

This will be a prospective, randomized, observational study. All implants will be placed in either the maxilla or mandible and loaded within 2 months with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.

This clinical study will evaluate patients being treated with the Tapered Screw Vent (TSV) dental implant and determine its safety and performance (effect of treatment of edentulism). The patients treated will experience more benefit from treatment of edentulism with the TSV dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years).

Specific objectives include:

1. The integration success measured by lack of mobility and resonance frequency assessment
2. The measured changes in peri-implant crestal bone levels
3. Confirmation of clinical benefits Up to 5 sites will be asked to participate (multicenter study); each site will be selected to place implants (approximately 120 implants across all sites, or 30 implants per site) in patients (any geographic region). The duration of the study will be approximately 2.5 years (last follow up visit is at 2 years) from initiation to completion of data analysis and reporting.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either sex and at least 18 years of age
2. Patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla.
3. Prior extracted sites or simultaneous extraction/ implant placement
4. Patients must be physically able to tolerate conventional surgical and restorative procedures.
5. Patients who provide a signed informed consent
6. Patients who agree to be evaluated for each study visit.

Exclusion Criteria:

1. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
2. Patients who have previously failed dental implants at the site intended for study implant placement
3. Patients with HIV or Hepatitis infection
A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors

The purpose of the study is to evaluate the safety and tolerability of HLX60 combined with HLX10 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each combination regimen.

Accelerated titration and "3 + 3" dose escalation were used in this trial . various doses of HLX60(anti-GARP) combined with HLX10(anti-PD-1) by intravenous infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed advanced malignant solid tumor, who have failed or cannot receive the standard treatment;
* With at least one evaluable lesion according to RECIST v1.1 (for solid tumors);
* Patients must be able to supply adequate tumor tissue for biomarker (including the expression of PD-L1, GARP) analyses;
* Life expectancy longer than three months;
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria:

* Has a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants with history of the second malignancy have been disease-free for \<3 years.
* Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening.
* Participant has unresolved AEs ≥ Grade 2 from prior anticancer therapy except for alopecia.
* Those who have received anti-GARP or anti-GARP/TGFβ complex antibody therapy.
Oral Mucosal Lesions Among Smokers in an Egyptian Population Study.

This cross-sectional study will assess the prevalence of oral changes among smokers in an Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo University), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in Egypt

The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Eligibility Criteria:
Inclusion Criteria:

* Gender: males and females.
* Age: all age groups.
* Smokers.
* Individuals who agreed to sign the informed consent.

Exclusion Criteria:

* Individuals suffering from any systemic disease.
* Individuals on medications.
* Non-Egyptians.
CUrrent Practices of Intensive Care for the Management of Acute Respiratory Distress Syndrome in EurOpe.

This study seeks to gain a comprehensive understanding of current ARDS management practices across European ICUs, with a particular focus on the use of LTV and PP therapy, which have been shown to improve outcomes in ARDS patients. The primary objectives focus on evaluating how LTV and PP are implemented across different institutions, while secondary objectives encompass a broader assessment of other ARDS treatment strategies. These include mechanical ventilation approaches, including PEEP titration, the use of NMBAs, and advanced extra-corporal therapies like ECMO and extracorporeal carbon dioxide removal (ECCO2R). Additionally, the study will explore diagnostic methods and decision-making processes that guide ARDS management in diverse clinical settings.

This is a cross-sectional survey designed to collect data on the current practices of ARDS management in ICUs across Europe. The survey will be administered electronically, allowing for the efficient collection of responses from a broad and diverse group of healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

• Healthcare professionals (physicians and nurses) who are currently employed in an ICU that treats ARDS patients and are actively involved in their management.

Exclusion Criteria:

• There are no specific exclusion criteria for this study, as the aim is to gather as broad a range of perspectives and practices as possible from ICUs treating ARDS patients.
Enhancement of Motor Function with Reboxetine and Transcranial Direct Current Stimulation

The hypothesis of the study is that combination of reboxetine/tDCS is more effective in enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to reboxetine and tDCS alone. The protocol is designed as a within-subject, block randomized placebo-controlled double-blind crossover study.

One important feature of the human brain is the ability to undergo plastic changes and reorganization after learning and lesions of the nervous system. This ability is of major importance for the treatment of functional deficits after stroke. Stroke is the major disease leading to persistent functional disabilities in Germany. However, the success rate of therapeutic interventions, especially in chronic stroke patients, is still unsatisfactory. Thus, basic science is essential to discover new therapeutic options that bear the potential for translation into clinical practice. Recent evidence is pointing to modulating the motor cortical excitability in order to enhance motor function in stroke patients. For this purpose, reboxetine as a selective reuptake inhibitor of noradrenaline and transcranial direct current stimulation have proven effective in enhancing motor functions needed for daily life activities by 10-12%. These improvements were significant compared to placebo, but still clinically unsatisfactory. Thus, this protocol aims at enhancing the excitability modulatory effect of each single intervention through the combination of reboxetine and tDCS. The hypothesis of the study is that combination of reboxetine/tDCS is more effective in enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to reboxetine and tDCS alone.

The protocol is designed as a within-subject, block randomized placebo-controlled double-blind crossover study. 12 chronic stroke patients with persistent functional deficits of the arm and/or hand will be included. The primary outcome measure is the time needed to fulfill all subtests of the Jebsen Taylor test. All patients undergo four different conditions in four different sessions: 1) reboxetine + verum tDCS; 2) reboxetine + sham tDCS 3) placebo drug + verum tDCS 4) placebo drug + sham tDCS.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 86
* patient is contractually capable
* first-ever, ischemic stroke
* minimum time since stroke 9 months
* a paresis of the arm/hand muscles above 3 on the MRC scale

Exclusion Criteria:

* multiple cerebral lesions and associated residual deficits
* severe head trauma in the past
* seizures
* ferromagnetic implants in the head/neck region
* pacemaker
* a psychiatric disorder or neurological disease besides stroke
* intake of illegal drugs
* severe aphasia or cognitive deficits that impede contractual capability
* contraindications for reboxetine (seizures, glaucoma, prostate hyperplasia with urinary retention, cardiac arrhythmias, potential interactions with co-medication)
* pregnancy
* breast-feeding patients
Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Tina Gel Sweet Flower.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Active cutaneous disease
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Graft Versus Flap in Management of Proximal Penile Hypospadias

Proximal hypospadias (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . The management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. However, obtaining a favorable cosmetic outcome and functional straight penis is a major surgical challenge for such patients, and the ideal repair of proximal hypospadias remains the Holy Grail for hypospadias specialists.

The surgical plan for proximal hypospadias can be divided into single and staged operations. Single stage operations are often associated with high rates of complications and reoperations. Reportedly, complications occur in 20-50% of patients. Therefore, many pediatric surgeons are selecting staged procedures. Staged surgical repair of proximal forms of hypospadias has been proven to achieve successful both functional and cosmetic results. Although staged repair with inner preputial layer graft has regained popularity in the repair of proximal hypospadias; but Choosing between flaps or grafts to substitute the urethral plate in 2-stage hypospadias repair has been a matter of debate with no consensus in the literature.

Flaps have reliable blood supply that may be theoretically less liable for strictures or contractures. Grafts are more versatile, which can be used in primary and recurrent cases when healthy local skin is deficient.

In this study, our aim is to compare outcomes of grafts and flaps when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias (penoscrotal and scrotal types).

Eligibility Criteria:
Inclusion Criteria:

* Age: more than 6 months.
* Type of hypospadias: proximal penile hypospadias (scrotal and penoscrotal variants)

Exclusion Criteria:

* Age: less than 6 months.
* Perineal hypospadias.
* circumcised patients.
* Previous hypospadias repair
* Raised serum creatinine, coagulopathy.
Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

This is a multicenter, randomized, double-blind, parallel-group, dose-ranging, comparator-controlled study of the effect of pantoprazole on intragastric pH after successful endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of successful hemostasis and administration will continue for 72 hours after hemostasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be men or nonpregnant women at least 18 years of age
* Patients who present with a gastric or duodenal ulcer (major dimension of the ulcer must be ≥ 5 mm and ≤ 20 mm) with endoscopic appearance of spurting, oozing, or nonbleeding visible vessel (NBVV) Patients presenting with adherent protruding clot are eligible if, after removal of the clot by irrigation, the underlying lesion is classified as spurting, oozing or a NBVV. Patients with an actively bleeding ulcer or a NBVV within a hiatal hernia are eligible if the ulcer is located below the Z-line)

Exclusion Criteria:

* Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation
* Patients presenting with active bleeding and/or NBVV at 2 or more separate sites
* Patients with any severe concomitant diseases, eg, end-stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases
Prospective Epidemiological Study Of The Prevalence Of HLAB*5701 In HIV-1 Infected Patients

This study is a cross sectional observational study to evaluate the prevalence of HLA-B\*5701 in the major French ethnotypes.

Any HIV-1 infected subject will be eligible for this study including antiretroviral therapy (ART) naÃ-ve and experienced subjects irrespective of abacavir use, as well as subjects previously tested for HLA-B\*5701. Subjects will be approached during a standard clinic visit, and all subjects will be consented prior to any study specific procedure. Subjects will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B\*5701 status by central and local methodologies.


Eligibility Criteria:
Inclusion criteria:

* HIV-1 infected patients, ART naive or experienced over the age of 18 years.
* Patients must be either affiliated to or beneficiary of a social security category.
* Patient is willing and able to understand and provide written informed consent prior to participation in this study.

Exclusion criteria:

* none
MRg-NIRS Imaging System Breast Cancer Trial

This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a program to improve clinical management of women receiving breast magnetic resonance imaging (MRI).

This trial is designed to determine if the MRg-NIRS system will contribute significantly to improved clinical management of women receiving breast magnetic resonance imaging (MRI) by achieving diagnostic performance comparable to or better than dynamic contrast-enhanced (DCE) breast MRI alone.

The purpose of this clinical trial is to evaluate the addition of MRg-NIRS with and without contrast in 20 women with breast cancer. The women enrolled in the trial will be those who have a newly diagnosed breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Females age ≥ 18 years old
2. Participants capable of providing written informed consent
3. Women with a recent diagnosis of breast cancer.
4. Women who are in pre-surgical planning must have an estimated tumor size of 2.0 cm or less on available imaging.
5. Women who are in pre-surgical planning must have had a breast biopsy at least 10 days prior to the MRg-NIRS exam.

Exclusion Criteria:

1. Participants with absolute or relative contraindication to MRI:

   1. the presence of an electronic implant, such as a pacemaker
   2. the presence of a metal implant, such as an aneurysm clip
   3. claustrophobia
   4. renal failure (FDA's guidance for gadolinium of a creatinine clearance less than 30 mL/1.73 m2 BSA)
2. Pregnant women
3. Breast implants
4. Prisoners
5. Participants with visually inadequate healing from breast biopsy.
Genetic Determinants of Congenital Heart Disease Outcomes

The purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery. The goals will be to determine 1) if the oxidative stress pathway is an important one for therapeutic intervention in neonates with severe congenital heart defects and 2) if variants in the oxidative response pathway can be used to identify patients at increased risk for adverse outcomes.

For physicians caring for children with congenital cardiac defects, perhaps the greatest challenge is to improve the survival and functional outcomes of patients with severe defects requiring surgical repair or palliation in the first month of life. These cardiac defects can be associated with 5 year mortality rates of up to 30% with significant disabilities in many of the survivors. As with every medical condition, patient outcomes depend on the complex interaction of the disease process, the medical and surgical interventions to treat the disease, and the inherent capacity of the patient to respond to both the disease and its treatment.

For patients with severe cardiac defects, the greatest risk for morbidity and mortality occurs during and shortly after their neonatal surgical repair. During surgery to repair severe cardiac defects, the body is cooled and the heart is stopped. In many cases, blood flow to the vital organs is interrupted or restricted for a significant period of time while the aortic arch is reconstructed. This process places profound stress on the patient's capacity to tolerate these insults without sustaining irreversible injury to tissues such as the heart, brain, and kidneys. That there is such a wide range of outcomes after this surgery, even between patients with similar clinical features, suggests that there are important individual differences in patients' abilities to respond to this stress that is determined by differences in their genetic traits.

The importance of the interaction between the controlled trauma of the surgical environment and a patient's genetic background in determining patient outcomes has led to the new discipline of "peri-operative genomics." In this study, we will examine the contribution of gene-environment interactions to perioperative and short-term outcomes in neonates with severe congenital cardiac defects.

Eligibility Criteria:
Inclusion Criteria:

* d-transposition of the great arteries or single ventricle cardiac disease
* Less than or equal to 30 days of age
* Planned arterial switch operation or stage I surgical palliation (Norwood)with aortic arch reconstruction

Exclusion Criteria:

* Known trisomy 13, 18, or 21
* Any major non-cardiac anomaly that precludes the patient from cardiac surgery
Individualized Physical Exercise Training and Enhanced Protein Intake in Older Citizens During Municipality-based Rehabilitation

The study will investigate if: 1) individualized physical exercise training in combination with extra protein intake can increase measures on all three ICF-levels? 2) extra protein intake alone increases outcomes of usual care treatment?

Successful rehabilitation of the growing number of elderly citizens can lead to preservation of functional independence and improvement in the quality of life.

The aim of the study is to investigate the effect of an individually tailored physical exercise training program combined with increased protein intake in order to improve measures on all three ICF levels (International Classification of Functioning, Disability, and Health). By conducting the study in a real-life clinical setting, research is translated into practice involving health professionals and the target group in the development of new knowledge on how to enhance the outcome of rehabilitation, thereby increasing the overall capacity of the elderly citizen, and decreasing the expenditure of health-services.

Eligibility Criteria:
Inclusion Criteria:

All citizens that are referred to the health/rehabilitation center age 65 years and older from Slagelse municipality will be invited to a screening interview with a physiotherapist after which the participant will be asked to join the study if not subject to one of the following exclusion criteria's:

Exclusion Criteria:

* inability to speak or read Danish,
* renal diseases,
* active cancer,
* upper or lower limp amputations,
* milk/lactose allergy or intolerance,
* hypertension \>180/110,
* pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis),
* progressive somatic or psychiatric diseases which can affect the course of training,
* referred to rehabilitation primarily due to gynecological and neurological conditions (apoplexies) or surgeries where movement restrictions are recommended,
* daily medication that may have an impact on muscle protein synthesis,
* alcohol intake greater than 14 units per week,
* discouragement from a general practitioner.