cyrilzakka/clinical-trials huggingface dataset:
Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles

A randomized controlled trial comparing the ongoing pregnancy rate (primary end-point) in 280 patients undergoing IVF/ICSI after stimulation with hp-hMG or rFSH controlled with a GnRH antagonist. Non significant differences were observed between hp-hMG and rFSH in terms of the ongoing pregnancy rate per started cycle (35.0% vs. 32.1%; p=0.61); R.R: 1.09 (95% CI: 0.78-1.51; Risk Difference: 2.9%). No differences were observed for implantation, clinical pregnancy and pregnancy loss rates. Patients receiving rFSH obtained more oocytes (14.4 ± 8.1 vs. 11.3 ± 6.0; p=0.001). Estradiol was higher at the end of stimulation in the hp-hMG group, while Progesterone was higher in patients stimulated with rFSH.


Eligibility Criteria:
Inclusion Criteria:

* women with good physical and mental health
* aged 18-37 years
* regular menstrual cycles ranging from 25 to 35 days; body mass index (BMI) \< 30 kg/m2
* normal basal serum FSH (≤ 10 IU/L) and E2 (≤ 75 pg/mL) levels determined on the day 3 of the cycle previous to COH
* no uterine (fibroids, adenomyosis, mullerian malformations), ovarian (endometrioma, polycystic ovaries) or adnexa (hydrosalpinx) abnormalities assessed by vaginal ultrasound.

Exclusion Criteria:

* patients with a history of recurrent pregnancy loss
* any significant systemic disease, endocrine or metabolic disorder
* having concomitant medication interfering with the purposes of the study
* patients who have received any ovulation induction drug within one month before their inclusion in the study.
Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia

The purpose of this study is to evaluate the effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events, to evaluate the effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelet recovery (CRp) at one-month post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CD33 positive, resistant or relapsed AML.
* Patients \> 18 years of age.
* ECOG performance status 0-2.

Exclusion Criteria:

* Fever (\>38), chills or hypotension (systolic BP\<105mmHg) in the 48 hours preceding therapy.
* Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of enrollment.
* Participation in any other Mylotarg® protocol.
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.

This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. Subjects will be followed for approximately 70 days post dosing.

Eligibility Criteria:
Inclusion Criteria:

* Positive for COVID-19 by an approved antigen test
* Mild symptoms consistent with a COVID-19 viral infection
* Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol
* Willing to follow contraception guidelines

Exclusion Criteria:

* Evidence of moderate COVID-19 per FDA severity categorization
* Pregnant or lactating and breast feeding or planning on either during the study
* Has a documented infection other than COVID-19
* Has received a COVID-19 vaccine
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
Linezolid in Healthy Volunteers

Linezolid is the first synthetic antibiotic of oxazolidinone group that can inhibit bacterial protein synthesis. Previous studies have found that linezolid was an effective treatment for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). In addition, the current dosage recommendation (1,200 mg/day) occasionally resulted in serious adverse events including bone marrow suppression and peripheral neuropathy.

The objective study were determine the pharmacokinetics of oral linezolid 300 mg /day in healthy volunteers. This study conducted in six healthy volunteers. All subject received an oral linezolid 300 mg/day by directly observed treatment (DOT) at the same time each day for 5 days. Blood samples were collected on day 5 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h post dosing. The separated plasma samples were evaluated by ultra-performance liquid chromatography (UPLC). All pharmacokinetic parameters were calculated.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 - 40
* BMI 19 - 24 kg/m2
* normal CLcr
* normal liver function

Exclusion Criteria:

* Subject who pregnant
* Subject who have documented hypersensitivity to linezolid
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.

This will be a prospective, first in man, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.

Reduction in tumor size 30 days after DaRT insertion will be assessed.

Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Eligibility Criteria:
Inclusion Criteria:

1. Histopathological confirmation of squamous cell carcinoma.
2. Tumor size ≤ 5 centimeters in the longest diameter.
3. Age over 18.
4. Women of childbearing potential will have evidence of negative pregnancy test.
5. Life expectancy of more than 6 months.
6. Performance status 2 (ECOG scale) or less.
7. Signed informed consent form.

Exclusion Criteria:

1. Tumor maximal diameter \> 5 centimeters.
2. Tumor of Keratoacanthoma histology.
3. Performance status ≥ 3 (ECOG scale).
4. Patients with moribund diseases, autoimmune diseases or vasculitis.
5. Patients under immunosuppressive and/or corticosteroid treatment.
6. Volunteers that participated in other studies in the past 30 days.
Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers

A randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. Based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. This trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advandced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab
* 18 years old or older
* Measurable disease per RECIST criteria

Exclusion Criteria:

* Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.
* Patients whose treatment plan is to receive ipilimumab or other anti-CTLA4 monoclonal antibody in combination with either nivolumab or pembrolizumab.

  * Ipilimumab and nivolumab combination are not eligible for this trial.
  * (Note: Patients whose planned treatment is the combination of anti-PD-1 and tyrosine kinase inhibitor such as pembrolizumab-axitinib or the combination of traditional cytotoxic chemotherapy and anti-PD-1 are eligible)
PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed written informed consent
* 40 - 80 years of age
* Clinical history of COPD with airflow limitation that is not fully reversible
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
* A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
* Able to change COPD treatment as required by protocol

Key Exclusion Criteria:

* Women who are pregnant or lactating
* Primary diagnosis of asthma
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Active pulmonary diseases
* Prior lung volume reduction surgery
* Abnormal chest X-ray (or CT scan) not due to the presence of COPD
* Hospitalized due to poorly controlled COPD within 3 months of Screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
* Cancer that has not been in complete remission for at least 5 years
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined in the protocol
Investigation of the Relationship Between Digital Game Addiction and Musculoskeletal System Disorders

The aim of this study is to examine the effects of digital game addiction on the musculoskeletal system and the reflections of these effects on the quality of life of adults.

This study will be conducted with a cross-sectional design in order to examine the relationship between digital game addiction and musculoskeletal disorders. The methods to be used in the research are as follows: Participant Information: The study will include adults aged 18-39 who play digital games in internet cafes for at least 3 hours a day, 4-5 days a week. Participants will be asked to fill out a form to collect demographic information. This form will include information such as age, gender, weekly game playing frequency (by hour and day), and physical activity levels. Scales to be Used: The following measurement tools will be used in the study to evaluate the effects of digital game addiction on the musculoskeletal system. Digital Game Addiction Scale, Arm, Shoulder and Hand Problems Questionnaire, Pittsburgh Sleep Quality, Cornell Musculoskeletal Disorder Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-39.
* Individuals who play digital games at least 4-5 days a week, at least 3 hours a day.
* Individuals who voluntarily participate in the study and sign the ethical consent form.

Exclusion Criteria:

* Individuals with existing serious health problems related to the musculoskeletal system or sleep patterns.
* Individuals who suffered trauma or serious injuries related to the musculoskeletal system during the study period.
* Individuals with psychological disorders such as depression or anxiety disorder.
Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion. 220 adult patients scheduled for routine cardiac catheterization will be enrolled. They will stratified according to the presence or absence of DM, or an estimated GER of less than 60 ml/hr before being block-randomized to the two groups. The incidence of CIN will be determined based on the average of two measurements of creatinine level before and 48 hours after the procedure, and an increase of 25% or 0.5 mg/dL (44.2 umol/L) or more.

Eligibility Criteria:
Inclusion Criteria:

All adult patients (18 years and above) who are scheduled for cardiac catechization and have abnormal but stable renal function will be eligible for enrollment. Abnormal renal function is defined as a creatinine level exceeding the normal range (more than 115 or 96 um/L in males and females, respectively, in KFSH\&RC laboratories) or eGFR less than 60 ml/min

Exclusion Criteria:

Patients who fall under any of the following categories will be excluded:

* Acute renal failure
* Cardiogenic shock
* Emergency cardiac catheterization
* Preexisting peritoneal or hemodialysis
* Pregnancy
* Recent exposure to contrast agent within the last 3 days
* Allergy to contrast or any of the above treatment
* Renal transplant,
* Patients who received dopamine, mannitol, theophyllin or other medications known to affect renal function within one week from cardiac cath
* Pulmonary edema / congestive heart failure
* Use of N-acetylcystein
* Patents on NSAIDS who can not stop using them for 48 hrs before and 48 hrs after procedure (except Aspirin).
The Effects of Using an Ergonomic Chinrest When Playing the Violin

A one-day crossover randomised trial was conducted to compare violinists using an ergonomic chinrest (EC) with do-as-usual on muscle activation, kinematics and sound. After two weeks of testing the EC, self-perceived evaluations on comfort, performance, sound, neck alignment and muscle tension were reported in a questionnaire between EC and do-as-usual.

The main question is to answer if:

1. the EC is superior compared to do-as-usual and gives a more aligned neck posture and less muscle tension/dynamic muscle activity
2. the EC is subjectively evaluated as better than do-as-usual regarding self-perceived comfort, performance and sound

The purpose of this study is to investigate the measurement of neck kinematics, muscle activation and sound when using EC and a usual chinrest and, additionally, their self-reported experience of neck alignment, muscle tension, sound experience, performance, and comfort.

It is a crossover, block randomised (block sizes of 4) and within-subjects experimental design performed in one day. The design was made to compare an ergonomic chinrest used with a low shoulder rest (EC) with preferred chin and shoulder rest (do-as-usual) in a randomised order and the effect on muscle activation, kinematics and sound. The study also includes a two-week familiarisation period testing the EC before the test day (crossover design). After these two weeks, a questionnaire was given to register self-reported performance, comfort and sound experience.

Furthermore, the participants were asked in an SMS about what ergonomic equipment they used after half a year (the EC, do-as-usual or other equipment).

On the test day, all participants played with both setup an excerpt of a music piece (second movement from W. A. Mozart's violin concerto no. 5 in A major),

The required sample size was estimated based on a previous feasibility study of either being in an awkward or neutral position with the head. We aimed to recruit 38 professional violinists. A professional violinist was defined as having finished the music conservatory with the violin as the main subject or attending school enrolled in the last years (master/soloist player).

The protocol was initial feasibility tested, and we report this study using the Consolidated Standards of Reporting Trials (CONSORT) 2010 extension to randomised crossover trials.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* speak and write fluently Danish or English
* Professional violinists
* No severe pain symptoms in the neck or upper extremities (\<3) scored on a numeric rating scale from 0 (no pain) to 10 (worst perceived pain).

Exclusion Criteria:

* medical conditions that could influence the test result (pacemaker or life-threatening health disorders)
* trauma on the upper cervical spine or upper extremities within the last 12 months
* previous or planned shoulder/neck operation
* severe eczema on the neck and upper extremities.
The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD

This study aim to identify the therapeutic effect of azathioprine during infliximab(IFX) treatment in Crohn's disease (CD).Half of patients will receive azathioprine and infliximab combination therapy at the same time. The other half patients will be given infliximab therapy first and then receive azathioprine 14 weeks later.

Anti-tumor necrosis factor agents were widely used for many years and were proved to be most reliable drugs in Crohn's disease (CD). About one-third of the patients would develop a secondary lost of response after initiating IFX therapy in one year follow-up. Immunosuppressor was thought to be a useful agent to reduce loss of response rate of infliximab.But It remain unclear when should us add immunosuppressor during infliximab therapy.This study aim to find the most valuable timepoint to initiate combination therapy to maximize therapeutic effect and minimize the adverse effect.

Eligibility Criteria:
Inclusion Criteria:

- CD patients need infliximab and azathioprine combination therapy

Exclusion Criteria:

- patients had lost response to infliximab or azathioprine previously patients intolerable to infliximab or azathioprine patients need to use 5-Aminosalicylates(5-ASA) patients had participated to other clinical study in two months
Effectiveness of Different Incentive Models in Booster up the Second Follow up Response Rate

Aim to test the effectiveness of different incentive models for increasing the follow-up response rate in the current smoker subject.

According to the Hong Kong Census and Statistic Department, 10.5% of the Hong Kong population who aged 15 years or above are daily smokers (Thematic Household Survey Report - Report No. 59, 2016). The smoking prevalence was estimated from a thematic household survey that has been conducted every 2 or 3 years. Another population-based survey related to tobacco control is the Tobacco Control Policy-related Survey conducted by the Hong Kong Council on Smoking and Health and the University of Hong Kong. Both surveys were in a cross-sectional design and no follow-up was done. A cohort study with follow-up data could provide more insights for the causal relationship. However, most people are not willing to complete follow-up survey and the response rate is often low (Mellahi, 2016). The low survey response rate could lead to statistically bias in the research funding (Pit, 2014). Therefore, cohort surveys need to provide attractive monetary incentive to the interviewee to increase the response rate (Pit, 2014).

This study aims to assess and compare the 3-month response rate of a follow-up survey due to different financial incentive schemes. The findings will be used for a feasibility assessment of future cohort studies of evaluating tobacco control measures and public opinion, and exploration of appropriate incentive scheme.

Eligibility Criteria:
Inclusion Criteria:

* Aged 15 or above
* Cantonese or Mandarin speakers

Exclusion Criteria:

* Unable to provide a consent form
* Speak language other than Cantonese and Mandarin
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes

The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 3-18 years old.
* Clinical diagnosis of Type 1 diabetes.

Exclusion Criteria:

* Newly diagnosed with Type 1 diabetes with in the past month of study date.
* Contraindications to receiving 23 valent pneumococcal vaccines.
* Other conditions associated with compromised immunity and vaccine response.
* Primary or Secondary Immune deficiency.
* Previous receipt of PPSV-23 vaccination.
HFCWO in Hospitalized Asthmatic Children

To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.

A historically controlled pilot study was conducted in pediatric patients 18 months to 18 years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted to the pediatric intensive care unit. Upon receiving informed consent, patients were treated with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge, lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and bronchodilator treatments spaced at least four hours apart.

Eligibility Criteria:
Inclusion Criteria:

* Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease

Exclusion Criteria:

* Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)
* Those who regularly use HFCWO
* Any patient exhibiting an absolute contraindication to HFCWO therapy
* Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability
Clinical Application of Electrical Impedance Tomography for Individual Adjustment of Ventilator Settings

First clinical application of an algorithm for individual adjustment of ventilator settings using electrical impedance tomography.

In patients suffering from early Acute Respiratory Distress Syndrome (ARDS), an algorithm for individual adjustment of positive end-expiratory pressure and tidal volume will be applied. After optimization of ventilator settings according to the ARDS Network protocol, lung stress and strain, driving pressure, respiratory system compliance (Crs), regional ventilation delay and PaO2 / FiO2 ratio will be recorded. Subsequently, ventilator settings will be adjusted using an algorithm aiming at recruitment and avoiding tidal recruitment and overdistension using electrical impedance tomography (EIT). After 4 hours of EIT-based optimization ventilator settings, lung stress and strain, driving pressure, respiratory system compliance (Crs), regional ventilation delay and PaO2 / FiO2 ratio will be recorded again. The results will be compared to the ARDS Network approach.

Eligibility Criteria:
Inclusion Criteria:

* Acute Respiratory Distress Syndrome (according to Berlin Definition)

Exclusion Criteria:

* Hemodynamic Instability (defined as mean arterial pressure \< 65 mmHg OR heart rate \< 40 / min OR heart rate \> 150 / min OR cardiac index \< 2.0 l/min/m\^2 DESPITE adequate fluid resuscitation and adequate therapy with inotropes and / or vasopressors)
* Thoracic burns or severe skin injuries
* High frequency oscillatory ventilation
* Pregnancy
* Severe chronic obstructive pulmonary disease (GOLD IV)
* Esophageal varices \> grade I
* Esophageal resection
* Invasive ventilation prior to study inclusion for more than 72 hours after onset of ARDS
* Inspiratory oxygen requirement \> 80%