cyrilzakka/clinical-trials huggingface dataset:
Detection of COVID-19 (SARS-CoV-2) in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)

The objective of this study is to look for the presence of SARS-CoV-2 in the semen of patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.

This is a prospective monocentric, open-label, prospective study of male patients with CoV-2-SARS.

Eligibility Criteria:
Inclusion Criteria:

* Male patient between the ages of 18 and 65 who has read and signed the consent form for participation in the study.
* Outpatient or inpatient without signs of respiratory severity, likely to be mobile
* Patient whose medical condition warrants screening for COVID-19 by nasopharyngeal swab

Exclusion Criteria:

* Patient under protective custody, guardianship or trusteeship
* Patient not affiliated to the French social security system
* Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
Measuring Biting Force of Poly-amide Complete Dentures

Randomized clinical trial to compare between biting force of mandibular complete denture constructed from two different materials; metal reinforced polyamide and conventional PMMA,The null hypothesis of the study that there will not be a difference between biting force of the complete denture constructed from metal reinforced polyamide and PMMA

Polyamide resins used in dentistry exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response. Although flexural strength, modulus of elasticity and rigidity of nylon (polyamide) denture base materials are relatively low, they demonstrate great impact strength, toughness, and resistance to fracture. It was suggested that by adding glass fibers to polyamides, their stiffness and other mechanical properties could be increased. The flexural properties of nylon denture base materials has promoted their usage only in conditions like unyielding undercuts, pronounced tuberosities, tori and bulging alveolar ridges. In 2013 Wadachi etal compared rigidity of polyamide and PMMA when used as a denture base material and concluded that; the modulus of elasticity of polyamide was very low in comparison to PMMA and was lower than ISO standard, and so they recommended that polyamide to be used as a denture base material it should be reinforced with metal frame

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
2. Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
4. Free from any tempro-mandibular disease.
5. Good oral hygiene

Exclusion Criteria:

1. Neuromuscular disorder and orofacial disease.
2. Tempromandibular joint and muscle pain
3. xerostomia or excessive salivation.
4. Limited mouth opening
5. Abnormal tongue behavior and/or size.
6. Intraoral soft and hard tissue pathosis
The BC Psychosis Program Biobank and Database for Genetic Polymorphisms and Their Associations With Psychosis Disorder

The purpose of this study is to determine if candidate polymorphisms in brain-derived neurotrophic factor (BDNF) and catechol-o-methyl transferase (COMT) are predictive of psychosis disorder severity, symptomology, and resolution in patients at BCPP. A secondary objective will be to form a biorepository of blood and saliva samples from patients at BCPP so that further genetic, proteonomic and pharmacogenomic studies may be done to gain insight into the genetic basis of differences in psychosis disorder presentation and manifestation, and differences in response to antipsychotic drug treatment.

This is a population-based, genetic-association, candidate polymorphism study. It will involve a prospective and a retrospective component. A blood draw or saliva sample will be performed during the participant's admission to BCPP, which may occur at any point during the participant's length of stay. When a participant has been deemed 'Ready for Discharge' by his/her attending psychiatrist at BCPP, a full phenotype will be obtained via retrospective chart review. Genetic analyses and determination of protein levels will be performed after chart review. Following fulfillment of the primary study objective, the remaining blood and saliva samples will be stored in the biobank over the long-term.

Eligibility Criteria:
Inclusion Criteria:

* Admission to BCPP.
* Has provided written informed consent.

Exclusion Criteria:

* None.
Cystine Capacity Clinical Study (CysCap)

The purpose of this study is to determine whether urinary cystine capacity, an assay used to measure the amount of cystine in the urine, can be used to predict stone recurrence in patients with cystinuria.

Cystinuria is a rare genetic cause of kidney stones that leads to significant morbidity due to the recurrent nature of the disease. Despite recent advancements in knowledge about cystinuria, such as the discovery of the genetic defects that cause the disease, there have been very few studies of clinical determinants of recurrent stone formation. An optimal method of measuring cystine solubility in the urine has been lacking, and therefore response to pharmacologic and dietary therapy is often not known. Recently, a new assay to measure the amount of cystine in the urine was developed called Cystine Capacity, or CysCap. It is an assay that adds a pre-formed amount of cystine crystals to urine and measures the amount of cystine the urine can take up from the solid phase (in undersaturated urine) or gives up to solid phase (in supersaturated urine). This study seeks to examine how well this measure of urinary cystine predicts stone occurrence, with the ultimate goal of helping to guide therapy and preventing kidney stones in cystinurics.

This is an observational study over 3 years. Subjects who are enrolled in the study will perform semi-annual 24-hour urine collections. They will undergo imaging of the kidneys every 6 months to monitor kidney stone formation or growth, in order to correlate urinary parameters with clinical events. The study will examine how well the urinary cystine capacity predicts stone formation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed laboratory diagnosis of cystinuria will be included in this study. There will be no age barrier to inclusion, but included patients must be able to reliably collect urine for 24 hours. Men and women will be recruited equally and there are no restrictions for racial or ethnic origin in this study.
* Patient enrollment will require signing of an informed consent document approved by the Lenox Hill IRB.
* For children 8-18 years of age, signing an assent to participate will also be required.

Exclusion Criteria:

* Patients will be excluded if they cannot sign consent or assent.
* Furthermore if the patient cannot reliably collect urine for 24 hours or adhere to study follow up visit requirements.
Measurement of Arch Motion After Bunion Surgery

This study is an observational "change from baseline" outcome measures design. Data is collected for the sake of evaluating treatment (fusion surgery) performed as standard medical care, but the investigator does not assign specific interventions to any participants in this study.

Device/fluoroscopy measurements of arch motion and questionnaire data will be acquired on 10 women undergoing surgery for bunion, and 10 controls. Surgery will implant hardware to fuse (stabilize) the arch. Methods will evaluate the patient's problems associated with bunion and satisfaction with surgery, and assess the effectiveness of surgery in reducing motion of the arch. The hypotheses are that patients treated with surgery will demonstrate improvement in function, and that surgery will reduce motion of the arch postoperatively (posttest measures acquired 6 months after surgery), and in comparison to measures taken on a control group.

The data collected will come from a comprehensive examination. Methods will include the measurement of arch motion made by an examiner using a device and a fluoroscopic gait examination procedure, and completion of two medical questionnaires. The fluoroscopic acquisition of the digital images will be analyzed across the specified time dimensions of the gait cycle.

Device and fluoroscopy of measures of arch motion will be made at 2 time points on patients enrolled in this study: presurgery (baseline) and 6 months postsurgery. The questionnaire measurements of self-reported pain and function will be made at 4 time points: presurgery (baseline) and again at 3 months, 6 months, and 12 months postsurgery. Outcome measurements will be collected on control subjects at one time point only, on the day of their enrollment into the study.

Prospective studies have not characterized outcomes in patients receiving this type surgical fusion as part of the corrective treatment for bunion. Results have potential to improve surgical treatment outcomes and, improve upon the current methods of fluoroscopic motion analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Women.
* Able to comprehend the risks associated with the study.
* Able to complete the paperwork required for enrollment.
* Able to walk without assistance of another individual.

Exclusion Criteria:

* Pregnancy
* History of great toe, forefoot or arch surgery, or severe traumatic injury.
* Reduced ankle or great toe motion that impairs the ability to walk.
* Observed evidence of foot deformity other than bunion.
* Insensate to skin sensation testing which could indicate neuropathy.
A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants

This is a Phase 1, open-label, two-period, one-sequence, crossover drug-drug interaction study to assess the P-gp and BCRP inhibition potential of divarasib using digoxin and rosuvastatin as probe substrates, respectively, in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-childbearing potential
* Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Poor peripheral venous access
L.Fermentum CECT5716 in Treatment of Breast Pain

The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain

1. Type of study Nutritional intervention study, multicenter, randomized, blinded, parallel group included 25 women per group

   * Group 1: 3x109 cfu / day (n = 25)
   * Group 2: 6x109 cfu / day (n = 25)
   * Group 3: 9x109 cfu / day (n = 25)
   * Group 4: placebo (n = 25)
2. Statistical calculation of sample size. The calculation of sample size was calculated by the company SEPLIN Solutions Statistics. The primary endpoint was the bacterial count of in milk. The sample size obtained to observe a difference of 1 log10, with a power of 0.80 and a significance level of 0.05 was 20 volunteers per group.
3. Randomization Randomization was performed using a list of random numbers generated by computer. Subjects will be randomized in a strictly sequential.

   If a subject is removed from the test, the number that was assigned randomization not be reused again.
4. Overall design and outline of the study At visit 1 we require the informed consent of the patient. It will take the milk sample, we will review the implementation of the inclusion and exclusion criteria. Be randomized and explain the treatment guidelines to be followed, the data to be collected and medical appointments that must go (2 and 3 weeks). It will complete the pain assessment questionnaire (MQP) and nutrition survey.

   On visits 2, 3 and 4 corresponding to 1, 2 and 3 weeks of intervention will collect milk sample pain assessment survey and nutrition survey.

   Milk samples (5 mL) were collected aseptically in sterile tubes to be frozen immediately until analysis to be carried out within seven days.
5. Intervention duration The intervention will last three weeks.

Eligibility Criteria:
Inclusion Criteria:

· breast-feeding women

* Swelling and / or warmth in the chest
* Chest pain
* total bacteria count in milk greater than or equal to 3 log10 colony forming units (CFU) / mL,

Exclusion Criteria:

* breast abscesses, Raynaud syndrome,
* Antibiotic treatment
* Allergic to antibiotics
* Low expectation of compliance with the study protocol.
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder

This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment.

Study hypothesis: CBT is an effective treatment for adult ADHD.

ADHD, previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether CBT is more effective than drug therapy in treating ADHD symptoms in adults who have been resistant to previous drug therapies.

Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or drug therapy which may include new or previously taken drugs. Questionnaires will be used to assess participants' ADHD symptoms at study start and at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Adult ADHD of at least moderate severity
* On current drug therapy for ADHD

Exclusion Criteria:

* Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
* Current substance abuse or dependence
* IQ less than 90
* Suicide risk
* History of cognitive behavioral therapy
Treatment of Insomnia Secondary to Chronic Pain

Several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. It will also assess whether a combined treatment is any more or less effective for pain or for sleep. Finally, the study will assess whether any of these treatments leads to improvements in immune function.

The investigators' primary goal is to assess the extent to which three forms of cognitive-behavioral treatment (CBT for insomnia, CBT for pain, and combined insomnia \& pain) diminishes insomnia symptoms in patients with chronic pain compared to a group not receiving CBT. This will be evaluated in a randomized trial with before and after evaluations using standard sleep diary measures of sleep continuity.

The investigators' secondary goal is to assess whether treatment responses to any of the interventions are associated with alterations in immune function.

The investigators' tertiary goals are to evaluate whether improved sleep has effects on patient reports of pain severity, frequency, and tolerability as well as on mood and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Ages 35-75
* Chronic non-malignant painful condition of the spine of \> 6 months duration
* Insomnia (\> 30 minutes sleep latency and/or wake after sleep onset time for \> 3 days/week for \> 6 months)
* Insomnia developed after the onset of the painful condition
* Preferred sleep phase between 10:00 p.m. and 8:00 am
* On stable medical regimen for medical and pain conditions (no surgery planned)
* Willingness to discontinue hypnotic medications

Exclusion Criteria:

* Unstable medical or psychiatric illness
* History of seizures
* Evidence of active illicit substance use or fitting criteria for ethanol (ETOH) abuse or dependence
* Symptoms suggestive of sleep disorders other than insomnia
* Polysomnographic data indicating sleep disorders other than insomnia
* Inadequate language comprehension
* Fibromyalgia
* Pregnancy
Ridge Preservation Comparing a Polylactic Acid Membrane vs. an Acellular Dermal Matrix Membrane

The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and resorbable membranes to determine if either provides a significant therapeutic advantage.

The control subjects will receive a bone graft in the extraction socket, plus an additional bone graft on the outside socket wall covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester. The test subjects will receive same type and technique of bone graft with a the acellular dermal matrix membrane to cover the bone graft. The membrane the patients receive will be randomly assigned using a coin toss: heads will be assigned to the test group while tails will be assigned for controls. The objective is to determine if at 4 months the width and height of the jaw bone and also the soft tissue thickness where the tooth was extracted has increased, decreased or remained the same. Also the amount of patients own newly formed bone will be determined by microscopic examination of a core of jaw bone that will be obtained from the site of implant placement immediately before the implant is placed (the implant is not considered part of the study).

Eligibility Criteria:
Inclusion Criteria:

* Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
* Healthy male or female who is at least 18 years old.
* Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

* Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
* Presence or history of osteonecrosis of jaws.
* Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
* Patients who have been treated with oral bisphosphonates for more than three years.
* Patients with an allergy to any material or medication used in the study.
* Patients who need prophylactic antibiotics.
* Previous head and neck radiation therapy.
* Chemotherapy in the previous 12 months.
* Patients on long term NSAID or steroid therapy.
* Pregnant patients.
Clinical and Laboratory Parameters of Myelodysplastic Syndromes at Upper Egypt

The aim of our study is to assess clinical \& laboratory parameters of adult Egyptian myelodysplastic syndrome patients in upper Egypt, its correlation with disease-free survival, overall survival (OS) and acute leukemia transformation.

The aim of this study is to assess clinical \& laboratory parameters of adult Egyptian myelodysplastic syndrome patients in upper Egypt, its correlation with disease-free survival, overall survival (OS) and acute leukemia transformation.

Materials and methods:

This study will be conducted in Sohag University Hospital and Assuit University Hospitals on available number of newly diagnosed patients with MDS according to the diagnostic criteria proposed by the WHO in 2016 .

full history taking, clinical assessment and certain laboratory investigations are conducted to every patient enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* De novo MDS according to WHO criteria diagnosis 2016

Exclusion Criteria:

* MDS on top of AML
A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy

This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).

This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of NK. Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).

All patients, with conventional or experimental treatment, will be treated for 19 days. A topical antibiotic will be added too as a concomitant treatment to all treatment groups, until the injury closes or according to medical criteria.

After signing informed consent, inclusion and exclusion criteria will be assessed, and if the patient meets all the requirements, the patient will be randomized.

After initiation of the treatment, patients will be follow-up at 2-3 days and once a week for 3 weeks. A final follow-up is planned at 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. NK stage 2 or 3 (Mackie classification)
3. Signed Informed Consent Form
4. The patient is able to understand the nature of the study and to participate throughout its duration

Exclusion Criteria:

1. Medical history of eye tumors
2. Active eye infection
3. Eyelid bad position or eyelid closure problems
4. Conjunctiva scarring
5. Topic chronic eye treatments with corticoids
6. Acute corneal burns (\<3 months)
7. Intolerance to contact lens
8. Allergy or inability to receive concomitant treatment with Exocin®
9. Patients with immunosuppressive or chemotherapy treatment
10. Pregnant woman or woman without proper contraceptive methods according to the investigator (\*), or lactating women
11. Participation in another clinical trial in the last month (\*) Contraceptive methods accepted in the protocol are: hormonal, intrauterine device (IUD), barrier methods, voluntary sterilization or the patient has menopause \>1 year duration