cyrilzakka/clinical-trials huggingface dataset:
Efficiency and Satisfaction With Telephone Consultation in Neuro-urology: Experience of the COVID-19 Pandemic

The COVID-19 pandemic has necessitated drastic measures in order to limit the spread of SARS-CoV-2. The stay home policies for the whole population and especially for frail patients and the express instruction to deprogram non-urgent consultations and interventions limited the clinic visits in neuro-urology department. In this context, telemedicine was seen as a pragmatic solution to provide follow-up care for our neurologic patients. Due to the delay in deploying telemedicine and the cognitive impairment of some of our patients, telephone consultation has been prioritized.

The COVID-19 pandemic might be an opportunity to review and refine our practices in neuro-urology. For the follow-up of selected patients, telephone consultations may be efficient and cost effective.

The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the physician and the patient.

The study was conducted in a neuro-urology department of a university hospital in France.

During the stay-home policies for the COVID-19 pandemic, all the scheduled medical visits were converted into telephone consultation. New patients weren't included.

For each teleconsultation, the physician assess the duration of the consultation, the number of tries to join the patient, the efficiency of the consultation, the difficulty to obtain relevant information due to the phone way of the consultation and the lack of physical examination.

On the next days, the patient was contacted by phone and was asked a) if he was satisfied of being phoned by the physician, b) if the teleconsultation was embarrassing, c) if he had enough time of teleconsultation d) if he got all the answers to his queries, e) if he would preferred to had a physical consultation f) to assessed the global satisfaction of the teleconsultation and g) if in the future, they may considered converting some clinic visits to teleconsultations.

The physician and the patient assessed whether this teleconsultation has replaced a physical visit.

The usual transport mode of the patient for a clinic visit and the need to take a day off for worker patients were recorded.

The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The primary outcome was the evaluation of the efficiency of the telephone consultation by the physician on a numerical 10-points scale. The secondary outcome was the evaluation of the satisfaction of the telephone consultation by the patient on a numerical 10-points scale.

Four hundred teleconsultations are scheduled for five physicians.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Telephone consultation

Exclusion Criteria:

* New patient in the department
A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.

This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing potential) participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4 nights (including Period 1 and Period 2).


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants of non childbearing potential must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
* Male and female participants of non-childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure (BP), pulse rate, oral temperature, and 12 lead electrocardiogram (ECG).
* Body mass index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight greater than 50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Clinically significant infections within the past 3 months prior to the baseline visit (for example, those requiring hospitalization or parenteral antibiotics, or as judged by the investigator), evidence of any infection within the past 7 days prior to the baseline visit, history of disseminated herpes simplex infection or recurrent (\>1 episode) herpes zoster or disseminated herpes zoster.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
* Malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* A positive urine drug test.
Renal Artery Calcium and Hypertension

CT of the abdomen is a very common examination performed for various indications.One of the common findings is vascular calcifications including calcifications of the renal arteries.Calcifications in the carotid arteries and coronary arteries are good predictor for obstructive atherosclerotic disease.Stenosis of the renal arteries can cause symptomatic or asymptomatic hypertension with subsequent clinical sequelae. Therefore early diagnosis of this condition is imperative.

The goal of our study is to investigate the correlation between incidental calcifications of the renal arteries in CT examinations and the presence of actual stenosis of these vessels in patients with and without hypertension.

Every patient aged 30-100 referred for abdominal CT examination with IV contrast injection will be included in this study (total 300 patients.Prior to the examination relevant clinical data including history of hypertension and predisposing conditions for atherosclerotic disease, will be investigated. The patient will undergo conventional CT with no special procedures. The images will be review by the radiologist for the presence of renal arteries calcifications, renal arteries stenosis,plaque location, plaque burden and characterization and secondary renal pathology.

This study will not change the examination technique and is not associated with any inconvenience to the patients.

Eligibility Criteria:
Inclusion Criteria:

* Every patient referred fo abdominal CT aged 30-100

Exclusion Criteria:

* Contraindication for IV contrast injection failure to demonstrate renal arteries with contrast refusal to sign an informed consent
Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia

The objective of this study is to determine the best insulin regimen for hospitalized patients who receive high doses of steroids who have high blood glucose.

The overall study objective of this research is to establish the efficacy and assure the safety of achieving glycemic control in hospitalized patients who receive greater than physiologic doses of steroids. This study will compare 2 methods of achieving glycemic control in hospitalized patients who develop steroid-induced hyperglycemia (blood glucose (BG) \>180 mg/dL): 1) a study-specific steroid NPH dosing algorithm plus standard recommended care (Experimental group) vs. 2) the standard recommended care (Methodist Hospital Complete Insulin Orders (Control group).

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥18 years who receive steroids in doses greater than physiologic replacement levels of ≥ 10 mg Prednisone or its equivalent of dexamethasone or methylprednisolone.
* Have signed the consent form for the study
* Have a BG \> 180 mg/dL any time during the first 24 hour of steroid administration that is above physiological replacement ( ≥ 10 mg Prednisone or equivalent)
* Are scheduled to be in hospital ≥ 2 days.

Exclusion Criteria:

* Unable to read or understand English
* History of psychiatric disability affecting informed consent or compliance with drug intake
* Type 1 diabetes
* Acute or chronic renal failure (creatinine clearance \< 30 mL/min estimated by method of Cockcroft and Gault)
* Patients in Hospice Care
* Age \<18 years
* Previously enrolled in this study.
* Not appropriate for the steroid protocol in judgment of the principal investigator and/or attending physician.
Metabolic Syndrome in Patients With First-episode Schizophrenia

The metabolic syndrome (MetS) is highly prevalent in patients with schizophrenia and is a major risk factor of type-2 diabetes, cardiovascular disease and early death. Genetic factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible causes of developing metabolic syndrome. Several studies have investigated the metabolic side-effects of antipsychotic medication. However it is still unanswered how unhealthy lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping disturbances adds to the metabolic risk of patients with schizophrenia. The aim of this study is to investigate the prevalence and development of MetS in first-episode patients with schizophrenia and 1 year after onset of treatment. The study's main hypothesis is that physical inactivity, regardless of medication, is an independent risk factor for metabolic syndrome in patients with schizophrenia. In comparison inpatients with major depression and healthy controls, both matched on gender, age and level of education will be included in the study. It is anticipated that the study's results will provide new knowledge about the risk of developing metabolic syndrome in first-episode schizophrenia and how different risk factors contribute to this.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ICD-10 diagnosed schizophrenia

Exclusion Criteria:

* Antipsychotic medication \> 6 weeks before inclusion
* Physical disability
* Pregnancy
* IQ\< 55
Gene Therapy for Achromatopsia (CNGA3)

A clinical trial of adeno-associated virus vector (AAV) CNGA3 retinal gene therapy for patients with achromatopsia

CNGA3 retinal gene therapy for patients with achromatopsia

Eligibility Criteria:
Inclusion Criteria:

* Are aged years or over
* Have achromatopsia confirmed by a retinal specialist investigator

Exclusion Criteria:

* Are females who are pregnant or breastfeeding
* Have participated in another research study involving an investigational medicinal therapy for ocular disease within the last 6 months
* Have any other condition that the investigator considers makes them inappropriate for entry into the trial
Study of Binaural Squelch Effect in Unilateral Otosclerosis

Patients with unilateral transmission hypoacusis due to otosclerosis undergoing stapedectomy surgery will be prospectively included.

They will be undergoing a free field vocal audiometry using the Oldenburg MATRIX software to evaluated the squelch effect gain between audiometry before and after 9months after surgery.

Our hypothesis is to show a squelch effect with the rehabilitation of the binaural audition.

Otosclerosis is one of the main causes of transmission hypoacusis. It can be treated with stapedectomy surgery.

But the understanding ability in noise has not been really studied. The Oldenburg MATRIX test is a well know test in audiology and allow to study the understanding in noise.

This study included all the patients coming in our center for stapedectomy for otosclerosis with controlateral audition under 30 decibels (dB) loss.

They will all undergo the MATRIX test in three situations: vocal material and noise from the front of the patient (S0N0 situation); vocal material from the front and noise from the bad-earing side (S0N-90 situation); vocal material from the front and noise from the good-earing side (S0N90 situation).

This might give three informations:

-Squelch effect which is the difference between Speech Reception Threshold (SRT) in S0N90 situation at 9month after surgery and before surgery.

The squelch effect is the ability of cortical discrimination to extract spatial cues and information providing from two different sources. So we considered the situation before surgery as a unilateral condition and the surgery rehabilitation as a bilateral condition.

* Head Shadow effect which is the difference between S0N90 and S0N-90 audiometry situations. The head shadow effect is the difference in the Speech Reception Threshold (SRT) due to diffraction effect of the physical sound wave.
* Binaural benefit which is the difference between S0N0 situation after and before surgery.

The binaural benefit is the SRT gain of both ear with same threshold comparing to a gap of threshold between the two ears.

The patients will also filled two questionnaires of quality of life: Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech and Spatial Questionnaire (SSQ).

The aim is to show the benefit of the surgery in otosclerosis for comprehension in noise.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of otosclerosis
* controlateral audiometry under 30dB loss
* the ear to be operated with a transmission over 30dB

Exclusion Criteria:

* otosclerosis which has already operated on the ear studied
* other cause of transmission hypoacusis
* transmission after surgery other 30dB
Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris

To see how well Naftin 1% cream works when applied once daily to the affected area. The results will be compared to those using a placebo cream, which is a cream with no active ingredient. Safety will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* Review and sign statement of Informed Consent and HIPAA authorization.
* Males or non-pregnant females ≥ 12 years of age to 17 years, 11 months, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
* The parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
* Presence of tinea cruris characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms.
* KOH positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
* Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations.
* Subject must be able to understand the requirements of the study and willing to comply with the study requirements.

Exclusion Criteria:

* A life threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
* Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.- Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
* Subjects with a known hypersensitivity to study medications or their components.
* Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
* Uncontrolled diabetes mellitus.
* Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
* Current diagnosis of immunocompromising conditions.
* Atopic or contact dermatitis.
* Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
* Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study (females who are surgically sterilized for at least 2 years are not considered to be of childbearing potential).
* Subjects using the following medications:

  * Topical anti-fungal therapy, powders or topical corticosteroids applied within 14 days prior to randomization. Terbinafine, butenafine, and naftifine (topical) within 30 days prior to randomization.
  * Oral anti-fungal therapies within 3 months of randomization (8 months for oral terbinafine).
  * Systemic antibiotic or corticosteroid treatment within 30 days of randomization.
  * Any other significant treatments, except hormonal contraception and multivitamin, at the discretion of the investigator that would interfere with study treatment.
Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients

Randomized clinical comparison of the serolimus eluting Cypher stent and the zotarolimus eluting Endeavor stent.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centers in Denmark can be included in the study.

Exclusion Criteria:

* The patient will not participate
* The patient participates in other randomized stent studies
* Expected survival \< 1 year
* Allergy to Aspirin, Clopidogrel or Ticlopidine
* Allergy to Sirolimus or ABT-578
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. This method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. The purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* presentation for colonoscopy
* male
* age 18 or older

Exclusion Criteria:

* women
* known inflammatory bowel disease
* presentation for emergency colonoscopy
* history of partial colectomy
* chronic narcotic or benzodiazepine use
Study to Determine Interaction Between the Use of Feminizing Hormone Therapy and Antiretroviral Agents Concomitantly Among Transgender Women

Objective

1. To determine pharmacokinetic (PK) DDI between GAHT and ARVs used as PrEP and ART among TGW
2. To evaluate ARV adherence among TGW

GAHT will be initiated on week 0. ARVs, either PrEP or ART, will be initiated on week 3. GAHT will then be withheld on week 5, and restart at week 8.

GAHT: Oral estradiol valerate 2 mg once daily and cyproterone acetate 25 mg once daily, which are the treatment of choice for GAHT in the TRC-ARC's Tangerine Community Health Center, will be provided to all participants.

PrEP and ART regimen: Generic fixed-dose combination of TDF 300 mg and FTC 200 mg will be used for PrEP and a generic fixed-dose combination of TDF 300 mg, FTC 200 mg and efavirenz 600 mg will be used for ART as recommended in the 2017 Thailand National Guidelines on HIV/AIDS Treatment and Prevention.

Eligibility Criteria:
Inclusion Criteria:

1. Thai nationality
2. Age 18-40 years old
3. Male-to-female transgender individual
4. PrEP/ART naïve
5. Body mass index 18.5-25 kg/m2
6. Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft- Gault equation
7. Alanine aminotransferase (ALT) ≤2.5 x ULN
8. Have signed the informed consent form

Exclusion Criteria:

1. Known history of allergy to hormonal or ARV component to be used in the study
2. Male-to-female transgender who underwent orchiectomy
3. Any of the following in HIV-infected participants

   * CD4 \< 350 cells/mm3
   * History of psychiatric disorder that may be worsening by taking EFV
4. Previous use of injectable GAHT in the past 6 months
5. Current use of any of the following medication:

   * Anticonvulsant: Phenytoin, carbamazepine or phenobarbitol
   * Ergot-containing agents: dihydroergotamine, ergotamine or other ergot derivatives
   * Sedatives: Midazolam or triazolam
   * Herbs: Gingko biloba, St John's wort or milk thistle
   * Anti-infective agents: Erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin or rifabutin
6. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Effect Of Resistance Training On Physical Fitness, Cognitive Ability, And Academic Performance In Young Adults

The goal of this study is to determine the effect of resistance training on physical fitness, cognitive ability, and academic performance in young adults. This would be a randomized controlled trail in which participants will be randomly allocated in to two groups. One group will perform resistance training and other group will perform balance and general body toning exercises.

In recent years, the relationship between physical fitness, cognitive ability, and academic performance has garnered significant attention in the fields of education, psychology, and sports science. Young adulthood represents a critical developmental period characterized by substantial physical, cognitive, and psychological changes. During this phase, individuals are often engaged in academic pursuits, which makes understanding the impact of various interventions on physical fitness, cognitive ability, and academic performance especially relevant.

While individual studies have explored the effects of resistance training on physical fitness, cognitive ability, and academic performance separately, there remains a gap in the literature concerning a comprehensive understanding of their interconnectedness in the context of young adults. This study aims to bridge this gap by investigating the potential causal relationship between resistance training and these multifaceted outcomes.

This randomized controlled trial will recruit participants from young population. Study participants will be randomized into two groups: Group-A and Group-B. Group-A participants would receive resistance training for 3 consecutive months, while Group-B participants would follow general fitness and body toning exercises. Physical fitness, cognitive ability and academic performance will be measured at the baseline and after the termination of intervention program.

Eligibility Criteria:
Inclusion Criteria:

* School going children between the ages of 12 to 17 year

Exclusion Criteria:

* Participants with any recent musculoskeletal injury that hasn't healed.
* Any deformity or disability that could affect the participant's ability to perform physical activity.
* Any systemic disease/disorder that could affect the physical and cognitive performance of the participants.