cyrilzakka/clinical-trials huggingface dataset:
The Impact of the Timing of Trigger on IVF Success

The aim of this study is to examine the length of ovarian stimulation with the timing of trigger in an IVF cycle and its potential to impact patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Planning to move forward with an IVF cycle
* Have met the requirements of being a patient at CCRM Colorado
* AMA: 39-44 years old And/or
* DOR: AMH \< 1 \& FSH \>10 (age independent)

Exclusion Criteria:

* Contraindication for pregnancy
* Have not fulfilled requirements for IVF cycle
* Single gene couple or chromosomal rearrangement
* Severe male factor or testicular surgical sperm removal (need sufficient sperm for ICSI)
* One ovary
* Uterine anomalies
* Stage III or IV endometriosis
* Explained recurrent miscarriage
* PCO or PCOS
* Using donor oocyte or gestational carrier
A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors.

Study details include:

* The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
* The visit frequency will be approximately every 21 days during study treatment.
* The study duration is estimated to be approximately 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
4. ≥ 1 measurable lesion per RECIST v1.1.
5. Able to provide an archived tumor tissue sample.
6. Adequate organ function.
7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).
8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).

Exclusion Criteria:

1. Prior treatment with B7H3-targeted therapy.
2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts).
3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline
6. Uncontrolled diabetes, or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s).
7. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A 12-week Digital Physical Activity Programme, With or Without Physical Education Support for Type 2 Diabetes Patients.

Investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing.

Primary objective: investigate the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing. Secondary objective: evaluate the effects on Cholesterol (ratio of High Density Lipids to Low Density Lipids), Resting Heart Rate, and Body Mass Index after a 12 week physical activity programme. Monitor step counts and sleep patterns during a 12 week physical activity programme.: Methods: Using a RCT is intended to implement dependent variable inductive research into a 12-week e-Health Physical activity (PA) programme with or without physical education support focusing on the blood glucose control in patients with T2DM. Recruitment of 60 patients from hospital out-patient clinics, community diabetic departments, and. NHS patients from general practitioners.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of T2DM in the last 3 years.
* Age 18+ years.
* Uses the English language as a primary or secondary language with the ability to read and write.
* Lives in the United Kingdom.
* Has no medical reason preventing participation in regular physical activity.
* Has a SMART phone with access to the internet.

Exclusion Criteria:

* Physical inability to participate in 12 weeks of physical activity.
* Cardiac or cardiovascular surgery in the past 6 months.
* Musculoskeletal issues that could be aggravated whilst participating in regular physical activity.
* Presently participating in a weight loss programme.
* Unable to commit to the 12-week feasibility study.
Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry

Atrial fibrillation is a rare cardiac arrhythmia in young (i.e. \<= 35-year-old) patients. Etiological factors, current management and mid- to long-term outcomes remain unknown.

Atrial Fibrillation in YOUNG patients (YOUNG-AF) is a prospective, observational, multicentric registry, including every consecutive patients aged \< 35-year-old with a diagnosis of atrial fibrillation. The registry will assess demographical, physical activity, toxicologic and genetic factors, as well as current management regarding anticoagulation, anti-arrhythmic drugs and catheter ablation. As an observational registry, patient will be managed with the guidelines-directed standard-of-care.

Eligibility Criteria:
Inclusion Criteria:

* First episode of atrial fibrillation
* Less than 35-year-old
* Diagnostic by 12-lead ECG or continuous monitoring (minimal duration 30 seconds)
* French Social Security number

Exclusion Criteria:

* Transvenous cardiac implantable electronic device (insertable cardiac monitors are not an exclusion criteria)
Uveitis in Relation to Perceived Stress: A Prospective Study

The purpose of this study is to conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress.

Patients presenting at The New York Eye and Ear Infirmary (NYEEI) who meet the inclusion criteria will be recruited prospectively. Patients diagnosed with non-infectious uveitis will be asked to self-administer the Perceived Stress Scale (PSS) - 10, following informed consent. Patient demographics will also be collected. The presence of inflammation will be then be assessed by the investigator. Patients will be asked to complete the PSS-10 again at all subsequent standard-of-care visits within a 6-month timeframe. PSS-10 scores are obtained by reversing the scores on the four positive items (4, 5, 7 and 8), then summing across all 10 items. Patient and the investigator will be masked to the PSS scores.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age with a diagnosis of non-infectious uveitis
* Able to self-administer the Perceived Stress Scale (PSS) - 10

Exclusion Criteria:

* Diagnosis of infectious uveitis
Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO]

This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients.

Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified.

So, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy.

However, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety.

Therefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up OCT examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (EPA and statin therapy group). Serial coronary angiography and OCT were performed at 9 months after baseline OCT procedure.

This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients by comparing 3 groups.

Eligibility Criteria:
Inclusion Criteria:

1. over 20 years
2. Patients implanted everolimus-eluting stent(EES) neoatherosccrelosis with neoatherosclerosis by OCT
3. LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin

Exclusion Criteria:

1. Patients taking omega 3 fatty acid before randomization
2. Patients allergic to rosuvastatin or eicosapentaenoic acid
3. Patients with a history of hemorrhagic stroke
4. Patients taking anti cancer agent
5. Patients undergoing LDL apheresis
6. Patients with severe liver disease or severe kidney disease
7. Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of rosuvastatin
8. Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of eicosapentaenoic acid
9. Patients performed percutaneous coronary intervention with restenosis of target lesion
10. Pregnant women or patients with possibility of Pregnancy or nursing woman
Reducing HIV in Adolescents

The purpose of this study is to assess the impact of a cash-incentivised prevention intervention on reducing HIV incidence rates in high-school learners in rural KwaZulu-Natal.

The impact of the cash incentivised intervention will be assessed using a matched pair, cluster randomised controlled trial design. The 14 selected high schools in the Vulindlela School Circuit will be matched in pairs. The matched pairs of schools will be the unit of randomisation. Baseline measurements, using a standardised tool (structured questionnaire and biological specimens) will be undertaken simultaneously in each matched pair and will include all eligibly enrolled and consenting learners in the respective schools. On completion of baseline measurements in each matched pair of schools, the randomisation code for the pair will be revealed and the intervention will be implemented in the intervention school. All schools will receive the same prevention intervention but only the intervention school will receive the cash incentives. Follow-up measurements will be undertaken approximately 12 and 24 months after implementation of the intervention using a similar standardised assessment tool to that used at baseline. At baseline and during follow-up assessments in intervention and control schools, linked HIV and substance use testing will be undertaken in all learners and pregnancy testing in female learners. Other secondary endpoints will be assessed using a structured questionnaire.

Eligibility Criteria:
Inclusion Criteria:

Learners must meet all of the following criteria at enrolment in order to be eligible for inclusion in the study:

* Male or female learner in Grade 9 or 10 in one of the 14 selected schools
* Willing and able to provide informed consent and/or assent to participate in the study
* Willing to provide locator data for home visits if necessary
* Not planning to move to another school or relocate in the next 36 months
* Willing to be finger-printed to verify identity for study procedure purposes
* Willing to participate in this study
* Willing to complete all study procedures

Exclusion Criteria:

* Refusal by the learner and/or parent or legal guardian to participate in the study.
* Unable to provide necessary informed consents
* Cognitively challenged learners
Qualitative Research Among Physicians and Junior Doctors Into the Preconditions for Implementing a CDSS Based on AI in the ICU

The goal of this study is to explore the different attitudes and preconditions of potential end-users (doctors \& physicians in training) required to achieve successful clinical implementation of models based on artificial intelligence (i.e. both machine learning and knowledge-driven techniques) as clinical decision support software.


Eligibility Criteria:
Inclusion Criteria:

* Medical specialist or specialist in training working in intensive care at the time of the study.

Exclusion Criteria:

* Age \< 18 yo
Peripheral Vision Training Study

This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training.


Eligibility Criteria:
Inclusion criteria:

* Right handed individuals
* Aged 19-89
* In good health as self-reported or visual impairments due to partial vision loss
* Normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss

Exclusion criteria:

* Younger than 18 or older than 89
* Being hearing-impaired
* Not in good health except due to partial vision loss
* Having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes
* Having hallucinations or delusions
* Having a current or past history of a substance abuse disorder
* Currently taking psychoactive medications
Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool

This study is designed to evaluate the effectiveness and implementation of the Assessment of Burden of Chronic Conditions (ABCC)-tool for patients with COPD, asthma, diabetes mellitus type 2 or heart failure (and any combination of these conditions) in real-life routine practice. The ABCC-tool consists of a questionnaire, a visualisation using balloons that is based on cut-off points, and treatment advice. The ABCC-tool is intended to be used in daily healthcare practice, is designed to monitor a patient's integrated health status over time, to facilitate shared decision making, and to stimulate self-management. The study has a pragmatic clustered quasi-experimental design with two arms. The intervention group will use the ABCC-tool and the control group will receive usual care. The study will be implemented at a general practice-level, and has a follow-up period of 18 months. The primary outcome is change in perceived quality of care, as measured with the Patient Assessment of Chronic Illness Care (PACIC), as compared to usual care after 18 months. It is hypothesized that the change in perceived quality of care is significantly higher in the group using the ABCC-tool as compared to the group that receives usual care. Additionally the implementation of the ABCC-tool in general practices will be evaluated in 12 general practices. The implementation study will evaluate the context of caregivers with the Consolidated Framework for Implementation Research, the process of implementation with the RE-AIM framework, and fidelity to the intervention with the fidelity framework.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis COPD, asthma, Diabetes Mellitus type 2 and/or heart failure
* can understand and read the Dutch language

Exclusion Criteria:

* COPD or asthma: used prednisone due to an exacerbation less than six weeks ago
* Heart failure or diabetes mellitus type 2: hospitalized less than six weeks ago
* Healthcare providers or patients who have already used the Assessment of Burden of COPD-tool are excluded from the control group
* Patients who have already used the Assessment of Burden of COPD-tool will be excluded from the intervention group
A Study of SGT-003 Gene Therapy in Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)

This is a multicenter, open-label, non-randomized study to investigate the safety, tolerability, and efficacy of a single intravenous (IV) infusion of SGT-003 in participants with Duchenne muscular dystrophy. There will be 2 cohorts in this study. Cohort 1 will include participants 4 to \<7 years of age. Cohort 2 will include participants 7 to \<12 years of age. All participants will receive SGT-003 and will be enrolled in the study for 5 total years for long-term follow up.


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: 4 to \<7 years of age
* Cohort 2: 7 to \<12 years of age
* Participants who are ambulatory. Ambulatory as defined as "being able to walk without the use of an assistive device."
* Established clinical diagnosis of DMD and documented dystrophin gene mutation predictive of DMD phenotype confirmed by Sponsor genetic testing.
* Negative for AAV antibodies.
* On a stable dose of at least 0.5 mg/kg/day of oral daily prednisone or 0.75 mg/kg/day deflazacort for ≥12 weeks prior to entering the study.
* Meet 10-meter walk/run time criteria
* Meet time to rise from supine criteria
* Participant has body weight: ≤50 kg

Exclusion Criteria:

* Treatment with dystrophin modifying drugs within 3 months prior to screening.
* Current or prior treatment with an approved or investigational gene transfer drug.
* Exposure to certain approved or investigational drugs within 3 months prior to screening or 5 half-lives since last administration, whichever is longer.
* Established clinical diagnosis of DMD that is associated with any deletion mutation in exons 1 to 11 or 42 to 45, inclusive, in the DMD gene as documented by a genetic report and confirmed by Sponsor genetic testing.

Other inclusion or exclusion criteria apply.
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets

This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.


Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.

  2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.

  3. Has at least one measurable lesion (based on RECIST 1.1) or bone metastases. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. 6. Understood and signed an informed consent form.

Exclusion Criteria:

* 1. Has received TRK inhibitors. 2. Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.

  3. Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.

  4. Has other malignant tumors in 2 years, except for cured or locally curable cancers.

  5. Has known spinal cord compression and cancerous meningitis. 6. Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.

  7. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.

  8. Obvious cardiovascular diseases. 9. Has a history of autoimmune disease, immunodeficiency. 10. Lactating women. 11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Efficacy of the Quell Wearable Device for Fibromyalgia

This study is designed for patients with primary fibromyalgia (FM) pain. The overall aim of the study is to determine the effect of the high frequency Quell device to manage FM compared with a low frequency device. Investigators hypothesize that those assigned to using the high frequency Quell device will report reduced pain compared with those using the low frequency Quell device; with those using the high frequency device also showing more improvement in sleep, mood, and level of activity. Investigators also hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain.

The Quell is battery powered with rechargeable batteries and is strapped to participant's upper calf with a velcro band. It has been cleared by the FDA for safety. It is designed to improve fibromyalgia by the principles of transcutaneous electrical stimulation of nerves much like a traditional transcutaneous electrical nerve stimulator (TENS) unit. Investigators expect to enroll approximately 130 subjects in this study. Participants will be equally randomized to one of two experimental groups: High Frequency Quell group (N=65) or Low Frequency Quell group (N=65). This study hopes to find out whether low frequency or high frequency stimulation is most useful among persons with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

1. have chronic pain related to FM for \> 3 months' duration
2. average 4 or greater on a pain intensity scale of 0 to 10
3. are able to speak and understand English
4. have a smartphone (Android or iPhone)

Exclusion Criteria:

1. diagnosis of cancer or any other malignant disease
2. acute osteomyelitis or acute bone disease
3. present or past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
4. pregnancy
5. any clinically unstable systemic illness judged to interfere with treatment
6. a pain condition requiring urgent surgery
7. an active substance use disorder, such as cocaine or IV heroin use (positive on the Mini International Neuropsychiatric Interview; M.I.N.I. v.5.0), that would interfere with study participation
8. have an implanted cardiac pacemaker, defibrillator, or other implanted device
Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects

Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI between 18.0 and 30.0 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History