cyrilzakka/clinical-trials huggingface dataset:
GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT

Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval.

Acronyms:

GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing GnRH-agonist OPU: ovum pick up NaCl: sodium chloride

It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU).

However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.

Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.

Eligibility Criteria:
Inclusion Criteria:

* Female age \< 40 years
* Baseline FSH and LH \< 12 IU/l.
* Body Mass Index \> 18 and \< 35 kg/m2
* No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities
* Patients with at least one embryo at transfer time

Exclusion Criteria:

* Very high risk of OHSS (\> 30 follicles \> 12 mm the day of ovulation triggering).
* Reduced ovarian reserve
* Fertilization failure
* Severe endocrinopathy
* Azoospermia
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne

The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.

The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female between the ages of 12 and 40 (inclusive)
* Written and verbal informed consent must be obtained.
* Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent
* Subject must have moderate to severe acne at the baseline visit
* Women of childbearing potential must be willing to practice effective contraception for the duration of the study

Key Exclusion Criteria:

* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
* Dermatological conditions on the face that could interfere with clinical evaluations
Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy

The purpose of this study is to see whether a phone-intervention called HOBSCOTCH will improve health, daily functioning and quality of life among patients with refractory epilepsy. HOBSCOTCH stands for "Home-Based Self-Management and Cognitive Training Changes Lives." This study will also help to find the best ways of integrating this telehealth intervention to routine clinic use.

The proposed project will assess the efficacy of an 8-week phone-delivered, experimental treatment called "Home-Based Self-Management and Cognitive Training Changes Lives" (HOBSCOTCH) on sixty patients with refractory epilepsy (PWRE). The investigators will employ a prospective, single blind randomized clinical trial design with wait-list controls to examine both objective and subjective measures of daily life, daily functioning, cognition, and emotional well-being. Investigators will also assess the impact of HOBSCOTCH on employment and work productivity using the Lam Employment absence and Disability Scale (LEAPS) and the Sheehan Disability Scale (SDS). Lastly, the investigators will examine whether changes in these domains are maintained three months after completion of the intervention. The study will expand the efficacy literature for HOBSCOTCH and further refine its use in a busy clinical environment, and therefore has potential to benefit the patient population (PWRE), who currently lacks treatment options besides the pharmacological and surgical care currently available.

Eligibility Criteria:
Inclusion Criteria:

* Patient is able to read and speak English.
* Patient has a reliable telephone connection and a private place they can use during the course of this study
* They do not have any treatment or intervention plan in place for the next 6 months. They may be on an anti-epileptic drug regimen that has not been changed in the past 3 months.
Effects of Non-invasive Ventilation on Function Diaphragmatic and Caval Distension

Introduction: Understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. Objective: Identify the acute effects of PEEP and ventilatory support pressure on thickening fraction, diaphragmatic mobility and vena cava distension in healthy people. Methods: This is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. Volunteers will undergo a NIV session, randomized into groups: CPAP, Bi-level and spontaneous breathing, without NIV support (control). The outcomes evaluated will be diaphragmatic ultrasound and inferior vena cava distensibility. The CPAP levels will be: 5, 10 and 15 cmH2O after 5 minutes of use and in the Bi-level group we will maintain the PEEP value at 5cmH2O and modify the pressure support values to the values: 5, 7 and 10 cmH2O pressure support, with all outcomes also being assessed after 5 minutes. Participants will remain in a supine position, with the right upper limb positioned behind the head, throughout the protocol and all measurements will be collected in the inspiratory and expiratory phases with volumes basal currents. For statistical analysis, intention-to-treat analysis will be employed and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary occurrences. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Elucidate the effects of different blood pressure levels on diaphragmatic function and inferior vena cava distension.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers;
* Age equal to or over 18 years old and under 50 years old.

Exclusion Criteria:

* Cardiopathy;
* Pneumopathy;
* Participants who develop any disabling condition that prevents completion of the protocol.
The Effect of Psychological State on Post Spinal Puncture Headache and Backache

To investigate the effect of patient mood before spinal anesthesia on post spinal puncture headache and backache

Before spinal anesthesia patients' anxiety and depression mood will recorded with Beck anxiety and Beck depression scale fifteen minute before spinal anesthesia.Seven days after surgery post spinal puncture headache and backache will assess by a telephonic interview

Eligibility Criteria:
Inclusion Criteria:

* patient scehedule surgery under spinal anesthesia
* between 18-80 years old

Exclusion Criteria:

* patients with psychiatric disorders
506U78 in Treating Patients With Refractory Hematologic Cancer

Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the response rate to compound 506U78 (2-amino-9-b-D-arabinofuranosyl-6-methoxy-9H-purine) administered as a 1 hour infusion daily for 5 days in patients with recurrent T-cell malignancies.

II. Determine the toxicities of compound 506U78 in this group of patients. III. Correlate the biochemical pharmacology of compound 506U78 (e.g., ara-G nucleotides in leukemic blasts and CSF concentrations) with clinical response.

IV. Determine the impact of compound 506U78 therapy on survival and duration of response of patients with recurrent T-cell malignancies.

OUTLINE: Patients are stratified according to disease characteristics: Group 1: T-cell ALL or NHL in first relapse (greater than 25% bone marrow blasts, with or without concomitant extramedullary relapse other than CNS); Group 2: T-cell ALL or NHL in second or later relapse (greater than 25% bone marrow blasts, with or without concomitant extramedullary relapse other than CNS); Group 3: T-cell ALL or NHL with positive bone marrow and CSF (greater than 5% bone marrow blasts and CNS 2 or 3 involvement); Group 4: Extramedullary relapse and less than 25% blasts in the bone marrow (excluding isolated CNS relapse)

GROUP 1: Patients receive a 1 hour infusion of compound 506U78 daily for 5 days in the absence of neurologic toxicity. The course repeats every 21 days. If a first relapse T-cell ALL study of higher priority is not open, then the patient may continue to receive the drug every 21 days for a maximum of 2 years provided that the patient has achieved a second complete response.

GROUPS 2 and 4: Patients receive compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. After 3 courses a patient may be given CNS prophylaxis with triple intrathecal therapy (TIT), consisting of methotrexate, cytarabine and hydrocortisone after consultation with study coordinator. TIT should be given every 12 weeks.

GROUP 3: Patients receive compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. TIT will be given on day 1 of weeks 1-4, 6, 9 and every 6 weeks for 12 weeks, and then every 9 weeks thereafter. This stratum is open.

Eligibility Criteria:
Inclusion Criteria:

* Refractory or recurrent acute lymphocytic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) with bone marrow involvement (T-cell disease only)
* Isolated CNS relapse not eligible
* Performance status - Karnofsky 50-100%
* At least 8 weeks
* Bilirubin no greater than 1.5 mg/dL
* SGPT less than 5 times normal
* Creatinine normal for age
* Creatinine clearance or GFR at least 60 mL/min/1.73m2
* No severe uncontrolled infection
* No concurrent biologic therapy
* Recovered from toxic effects
* At least 6 weeks from administration of nitrosoureas
* No concurrent endocrine therapy
* At least 6 weeks from administration of craniospinal or hemi pelvic radiotherapy
Phase III Study of ASP2151 in Herpes Simplex Patients

To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated

   * Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
   * Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
2. Patients who can start receiving the study drug within 48 hours after onset of rash
3. Age: 20 years or older, but younger than 80 years

Exclusion Criteria:

1. Patients who are not expected to have an adequate response to oral antiviral medication
2. An extreme decline in immune function
3. Presence of serious complications
4. Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

   * AST or ALT ≥ 2.5 x upper limit of normal
   * Platelet count \< lower limit of normal
   * Serum creatinine ≥ 1.5 mg/dL
   * Creatinine clearance \< 30 mL/min
5. Current or previous history of malignant tumor within 5 years before informed consent
6. Diagnosis of autoimmune disease
7. Evidence of bone marrow suppression
Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections

This is a study clinical, multicenter, Phase III trial, to evaluate the efficacy and safety of tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Study Clinical, multicenter, Phase III, to evaluate the efficacy and safety of 10mg/g tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, of any race, aged 12 years;
* Ability to understand and sign the IC (for patients older than age) in the case of minors monitoring and consent of a guardian;
* Clinical diagnosis of fungal infections for tinea pedis (ringworm of the feet) or tinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other body areas);
* Direct mycological exam positive for fungi;

Exclusion Criteria:

* Pregnant women or nursing mothers;
* Use of topical or oral antifungal;
* Use of steroids;
* Allergy or hypersensitivity to any component of product;
* Clinical cases of tinea infection by bacteria and / or eczema, tinea extensive and onychomycosis.
Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes

The purpose of this study is to determine if collecting information and blood from a group of people who never smoked but who have lung cancer, is possible across the US. The investigators will collect information on each patient's diagnosis and treatments. If the collection is successful, blood samples will be used to try to identify new genes (which are the basic elements of heredity, passed from parents to their offspring), which may explain and predict why certain patients develop lung cancer without having smoked tobacco.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* histologically and/or cytologically proven diagnosis of non-small cell lung cancer
* never smoker, defined as having smoked less than 100 cigarettes over one's life-time
* completed survey and inclusion form
* signed informed consent

Exclusion Criteria:

* previous history of cancer (other than lung cancer)
* living outside the United States
* patients who cannot read English (as website and questionnaires will only be written in English)
* unable to understand the protocol or to give informed consent
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients

This double blind, randomized study is aiming to evaluate the efficacy of three doses (1gr/day) of methylpredisolone added to standard therapy in patients, with documented COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation.

Patients recently hospitalized for the treatment of documented COVID-19 pneumonia who do not require invasive ventilation will be randomized (1:1) to receive current standard treatment, which may include desamethasone and oxygen, with methylprenisolone 1gr daily iv for 3 consecutive days or standard treatment alone.

Efficacy measures will be time to recovery (discharge from hospital), invasive ventilation prevention and survival.

Patients safety will be evaluated throughout the all study period.

Eligibility Criteria:
Inclusion Criteria:

1. age = 18 years;
2. Informed consent for participation in the study and for data processing;
3. Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;
4. Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);
5. Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;
6. PaO2 / FiO2 between 100 and 300 mmHg.
7. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days;
8. Serum CRP greater than 5 mg / dL;
9. Interval from onset of SARS-CoV2 infection symptoms to randomization\> 5 days-

Exclusion Criteria:

1. Invasive mechanical ventilation;
2. Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;
3. Pregnancy or breastfeeding;
4. Severe heart or kidney failure;
5. Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;
6. Diabetes not compensated according to the doctor's judgment;
7. Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment;
8. Steroid bolus therapy in the week prior to enrollment for the study;
9. Enrollment in another clinical trial;
10. Patient already randomized in this study-
Novel Exercises to Facilitate Recovery of Supination and Pronation for Distal Radius Fractures Managed With a Volar Plate

The primary objective of this study is to evaluate the influence of elbow position on achieving forearm supination and pronation and wrist ROM postoperatively. It is anticipated the results will show recovery of functional motion in a shorter period of time (27 days average). As for the secondary objective of the study, it is anticipated there will be limited pain and cost-containment. These data elements will serve as secondary factors to evaluate.

The current standard of care for forearm range of motion exercises is to position the elbow in 90 degrees of flexion at the side of the body for both supination and pronation.5,6 This study will compare standard of care forearm rotation exercises to exercising with the elbow in extension to facilitate pronation and exercising with the elbow in full flexion to facilitate supination in patients who have undergone surgery with a volar plate for distal radius fractures. We hypothesize that forearm motion will be achieved in a shorter number of days and with a greater arc of motion when the exercises are done in extremes of elbow flexion and extension.

This will be a prospective, unblinded, randomized study to evaluate forearm range of motion across two groups:

Control Group: subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.

Test Group: subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.

Randomization will occur post-operatively after the patient has signed consent to participate. Randomization will occur through a computerized random allocation and groups will be assigned by the Clinical Research Manager or designee.

Eligibility Criteria:
Inclusion Criteria:

* • Subjects 18 years of age and older

  * Subjects with distal radius fractures with a volar plate
  * Subjects attending therapy at the Indiana Hand to Shoulder Center or affiliated satellites.
  * Subjects that attend the initial therapy visit between 5 and 10 days postoperative and begin the home therapy program (patient handout)

Exclusion Criteria:

* • Subjects under the age of 18

  * Additional surgical procedures or other factors preventing early active ROM of the forearm and/or wrist within the initial 10 days following surgery
  * Pre-existing medical conditions or injuries with resultant limitation in elbow, forearm or wrist ROM, patient-reported limited function, or limited ability to comply with home program (cognitive skills).
  * While undergoing therapy the initial 6 weeks, subjects provided with custom-fabricated or pre-fabricated devices, orthoses, or braces for the specific purpose of passively improving ROM of the elbow, forearm or wrist during the initial 6 weeks of therapy.
Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR)

The purpose of this study is to compare adherence, persistence, and effectiveness among patients initiating tofacitinib Modified Release (MR) with tofacitinib Immediate Release (IR).


Eligibility Criteria:
Inclusion Criteria:

* At least one claim for tofacitinib between 01 January 2014 and 31 January 2017 (the identification period).
* Presence of The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) code for RA (in any position) during the one-year pre-index period or on the index date. ICD-9 = 714.0x-714.4x \& 714.81 or ICD10 = M05.\* \& M06.0\*-M06.3\* or M06.8\*-M06.9\*.
* At least 18 years old as of the index date.

Exclusion Criteria:

* Patients with claims for other conditions for which biologics are used during the one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study.
* Patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. Patients will be allowed to have been treated with other biologics approved for RA (Tumor-Necrosis Factor-alpha inhibitors (TNFi) \[adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), golimumab (Simponi), infliximab (Remicade)\] and non-TNFi's with alternative mechanisms of action \[abatacept (Orencia), and rituximab (Rituxan), anakinra (Kineret), tocilizumab (Actemra)\]) during the one-year pre-index period.