cyrilzakka/clinical-trials huggingface dataset:
Cervical Stiffness Measurement in Cervical Insufficiency

The goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies.

The central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. Cervical stiffness will be objectively measured by the closing pressure Pcl using the Pregnolia measurement device. This is performed during a speculum exam by placing the measurement probe on the ectocervix.

In current clinical care, there is no objective measurement of cervical stiffness. An accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. Successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women over 18 years of age.
2. Singleton gestation.
3. Gestational ages between 12w0d and 22w6d.
4. Candidates for cerclage
5. Normal controls, which will be matched to cerclage subjects by gestational age and parity

Exclusion Criteria:

1. Multiple gestation pregnancy.
2. Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta.
3. Chorioamnionitis
4. Preterm contractions
5. History of cervical surgery (LEEP, trachelectomy, conization).
6. Mullarian anomaly
7. Known carrier or HIV or Hepatitis B/C
8. Active genital infection
9. Communication problems (cognitively impaired adults unable to give consent)
10. Cerclage placement already performed this pregnancy
Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular

To observe the effects of vitreous cavity Balanced salt solution (BSS) tamponade on the state of the lens and related parameters of the eye, and whether the changes of the above parameters are correlated with age, gender, diabetes or not, etc., so as to provide references for the diagnosis and treatment of related diseases and scientific research.


Eligibility Criteria:
Inclusion Criteria:

* ① Patients undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases;

  * Patients who underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes; ③ Intraoperative BSS was used for fill the vitreous cavity; ④ Before treatment, inform the patient that the clinical data may be used in clinical research, and the patient and his family are informed and sign the informed consent.

Exclusion Criteria:

* ① The operation eye was intraocular lens or cataract extraction during operation; ② Suspensory ligament relaxation or rupture, ciliary body detachment or transaction, lens dislocation, endophthalmitis, traumatic cataract;

  * intraoperative lens injury; ④ patients who refused to participate in the study.
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)

This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, male or female patients ≥ 18 years old at index date
* Participants must voluntarily give written informed consent form (ICF). Patients must read and fully understand the ICF
* Participants with confirmed diagnosis of RMS at index date, diagnosed by the treating physician according to applicable clinical practice guidelines (currently McDonald 2017 criteria), with high disease activity.
* Required historical data should be available: number of relapses in the 12 months prior to index date, DMTs taken prior to index date, date of MS diagnosis, and data of at least 1 MRI prior to index date as specified in the drug Summary of Product Characteristics (SmPC)
* Fulfillment of the indication for treatment with cladribine tablets at index date, per standard of care in accordance with the local SmPC
* Meeting 1 of the following criteria:

  * Prospective participants: Having been prescribed with cladribine tablets or having taken at least one dose of cladribine tablets, with enrollment date prior to the second treatment week
  * Retrospective participants: Having taken at least one dose of cladribine tablets, with enrollment date during or after the second treatment week but not more than 3 years after the first dose of cladribine tablets

Exclusion Criteria:

* Contraindications to use of cladribine tablets according to the SmPC.
* Any participant who had the first dose of cladribine tablets more than 3 years prior to enrollment
* Any participant who is pregnant or plans to breast-feed while taking cladribine tablets, or any patient who or whose partner plans to become pregnant in Year 1 or within 6 months after the last dose in Year 2, or any participants who is unwilling or unable to use contraception per the SmPC
* Have participated or participating in an interventional study since cladribine tablet initiation, in which participant assessment and/or treatment may be dictated by a protocol
* Participants who, at the discretion of the Investigator, will not be able to provide reliable information for the study
Reintegrating a Systematic Review Consultation With the General Practitioner After the Cancer Diagnosis Has Been Announced Into the Complex Cancer Patient Pathway: Feasibility Study

This is a prospective, multicentric, regional study designed to assess the feasibility of setting up a summary consultation with a general practitioner (GP) to complement the consultation for the announcement of a cancer diagnosis.

171 patients will be included in the study.

Each patient will be followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient with a solid tumour whatever the organ.
3. Patient treated in one of the participating centres as part of a system for announcing the diagnosis of a solid cancer.
4. Patient undergoing cancer treatment in one of the participating centres.
5. Patient with a registered general practitioner in the Occitanie region.
6. Patient affiliated to a French Social Security scheme.
7. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria:

1. Patient already included in another clinical trial concerning a care pathway.
2. Patient deprived of liberty or under legal protection (curatorship and guardianship, safeguard of justice).
3. Pregnant or breast-feeding woman.
Influence of Lifestyle Modification Program on Meaningful Participation and Quality of Life of Independent Taiwanese Older Adults

The goal of this clinical trial is to compare the differences between health-related quality of life and meaningful participation among two groups.

The main question it aimed to answer are: whether the older adults from experimental group who received 24-week lifestyle modification program would have higher level of health-related quality of life and meaningful participation compared to those who did not receive the program from the control group. Participants in experimental group had to attend in a 24-week lifestyle modification program. Researchers will compare the experimental and control group to see if there were differences between their health-related quality of life and meaningful participation.

This study investigates the impact of a Lifestyle Modification Program (LMP) on the quality of life and meaningful participation of independent Taiwanese older adults. As the global and Taiwanese populations age rapidly, there's an urgent need to address the challenges posed by aging, including deteriorations in physical and mental health that affect independent living and well-being. Inspired by USC's Lifestyle Redesign® Program, this research aimed to adapt and evaluate a similar intervention in a Taiwanese context, considering cultural differences and specific needs.

Participants in the experimental and control groups were required to be over 55 years old, independently living in the community, proficient in Mandarin Chinese or Taiwanese, and showing no overt signs of psychosis or dementia. The study was conducted with ethical approval from Kaohsiung Medical University's IRB, ensuring confidentiality and informed consent.

The experimental group received the LMP which included 12 treatment modules delivered in 24 weekly group sessions, emphasizing active engagement, knowledge sharing, and personal exploration. The intervention aimed to foster psychophysical health, increase daily activity participation, and enhance overall quality of life through a large group format over a shorter timeframe than traditional interventions. The control group participants were selected from the same community without engaged in the LMP.

The study used the SF-36 Taiwan version to measure health-related quality of life and the Taiwanese Meaningful Activity Participation Assessment (T-MAPA) to evaluate the frequency and degree of meaningful participation, and then to compared the changed scores between the two groups in order to examine the efficacy of the LMP. Additionally, individual semi-structured interviews were conducted to acquire qualitative insights into participants' subjective experiences before, during, and after the intervention among the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* over 55 years old
* independently community-dwelling
* proficient in Mandarin Chinese or Taiwanese

Exclusion Criteria:

-show overt signs of psychosis or dementia
Periprocedural Glycemic Control in Patients Undergoing Coronary Angiography

There are 24 million people with diabetes mellitus (DM) in the United States. Over one-third of patients presenting for coronary angiography have known DM, and an additional 20% of patients without known DM present with hyperglycemia on the day of coronary angiography. Hyperglycemia in the setting of urgent and elective percutaneous coronary intervention (PCI) is associated with a 40% relative increase in long-term mortality regardless of diabetic status. Mechanisms linking periprocedural hyperglycemia to adverse outcomes are poorly understood and the effects of treatment are unknown. This is a pilot study aimed at determining the effectiveness, feasibility and safety of continuing long-acting hypoglycemic medications on the morning of coronary angiography. Since hyperglycemia may cause increased platelet reactivity, a secondary aim is to evaluate a possible mechanism of benefit of periprocedural glycemic control on platelet activity. Patients with DM on hypoglycemic medications undergoing coronary angiography will be randomized to either continue or hold their clinically-prescribed long-acting hypoglycemic medications on the day of procedure. Patients with and without DM will be randomized to either routine care or additional glycemic control with the Yale insulin infusion protocol for 6 hours post-PCI. The primary endpoint of this study will be mean blood glucose level at the time of arterial access in the hold versus continue groups. Secondary endpoints will be mean blood glucose level at 6 hours post-PCI in the Yale versus routine care groups and number of hypoglycemic events in the glycemic control versus no glycemic control groups. The exploratory analysis assessing the effect of glycemic control on platelet activity will guide further studies evaluating the translation of an individual's platelet phenotype to the clinical risk of increased long-term mortality following PCI. The outcomes for this study (glucose levels and platelet function) are all measured during the hospital stay which averages 1 day.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing coronary angiography at the Manhattan Campus of the VA NY Harbor Healthcare System

Exclusion Criteria:

* 1. Patients who do not or are unable to consent. 2. Patients participating in a competing study. 3. For platelet substudy, patients who took NSAIDs within 72 hours of blood collection or who are on cilostazol or dipyridamole as part of their routine medication regimen. 4. Patients with any other co-morbidities that would influence subject safety.
Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02

This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Age\<70
* Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
* A untreated squamous esophageal carcinoma
* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
* Adequate organ function
* No known history of drug allergy
* Blood routine examination : WBC≥4.0
* hepatic and renal function are normal

Exclusion Criteria:

* Age≥ 70 or \< 18
* Already received the treatment of chemotherapy or radiotherapy
* Pregnant or lactating females
* Known drug allergy
* Without agreement of informed consent form
* Insufficient hepatorenal function or Blood routine examination
* Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
Comparison of Core Stability and Otago Exercise on Balance and Quality of Life in Patients With Stroke

Core stability and otago exercise program has been proved to be effective in many conditions like muscles strenghing, gait improvement and relieving of pain. Hence the aim of present study is to compare the effectivness of Core stability and Otago exercise on balance and quality of life in patients with stroke.

The Otago Exercise Program (OEP), consist of resistance training and balance training exercises. The OEP is composed of three domains, namely muscle strengthening, balance training with a progression by increasing ankle cuff weights and number of sets, in association with a walking plan. It is a program that incorporates moderate intensity strength exercises focusing on the lower limbs and balance to be performed for about 30 min at least three times a weekStrength training consisted of flexion and extension exercises of the knee, ankle, and toe joints, as well as hip opening exercises to strengthen the sides of the pelvis. Balance training consisted of walking backwards, walking in a figure of eight, heel-toe walking, standing on one leg, walking on the heels, walking on the toes, heel-toe walking backwards, standing up from a sitting position, and walking up stairs.exercises and physical activities could promote balance, flexibility, muscular strength, and walking ability among elderly people.OEP three times a week, for 6 months, can improve dynamic balance.core stability exercises for five weeks in addition to conventional physiotherapy five days a week for the same period, improved dynamic sitting balance, standing balance, gait and activities of daily living at the post intervention assessment in subacute post-stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Sub acute stroke(3 to 6 months).
* Ashworth scale 1 to 3.
* Patients having cognition level is (26-30) according to MOCA.
* Patients having (21 to 42) score according to BBS.

Exclusion Criteria:

* Fractures.
* Participants with recurrent stroke.
* Participants with sever spasticity
* Orthopedic or other neurological impairment that could influence balance.
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.


Eligibility Criteria:
Inclusion criteria:

* Signed Informed Consent
* ErbB2(HER2)overexpressing breast cancer.
* Brain lesion(s) which are progressing.
* Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).
* Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.
* Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.
* Able to swallow an oral medication.
* Adequate kidney and liver function.
* Adequate bone marrow function.

Exclusion criteria:

* Pregnant or lactating females.
* Conditions that would effect the absorption of an oral drug.
* History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
* Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
* Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
* Patient must be currently on antiretroviral therapy (ART)

Exclusion Criteria:

* Patient less than 18 years of age
* Additional exclusion criteria will be discussed and identified by the study doctor
STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

The purpose of this study is to compare the activity of fixed doses of cisplatin and etoposide with toxicity adjusted dosing of the same drugs in the first-line treatment of small cell lung cancer.

The standard treatment for advanced small cell lung cancer (SCLC) is combination chemotherapy of cisplatin or carboplatin with etoposide. Standard fixed doses of this combination have been based on calculating a patient's body surface area. This method of dose calculation has been shown to be poorly correlated with the activity of many chemotherapy drugs, and some patients do not obtain adequate levels of the drug in their circulation. Recent reports suggest that patients who have a very high tolerability to chemotherapy (without significant toxicity), are at risk for having less effectiveness of the therapy. This study will compare fixed doses of standard chemotherapy with a new strategy of the same chemotherapy with doses that will be adjusted according to the toxicity observed.

Eligibility Criteria:
Inclusion Criteria:

* Cytologic or histologic diagnosis of small cell lung cancer
* Extensive disease according to VALG classification
* One or more target lesions.
* Performance status (ECOG) 0 or 1
* Age \<70 years.
* Patients with asymptomatic cerebral metastases are eligible
* Patients who have completed treatment with radiation therapy at least 4 weeks prior to enrollment are eligible
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy
* Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
* Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl
* Creatinine \> 1.5 x the upper normal limits
* GOT and/or GPT \> 2.5 and/or Bilirubin \> 1.5 times the upper normal limits in absence of hepatic metastases
* GOT and/or GPT \> 5 and/or Bilirubin \> 3 times the upper normal limits in presence of hepatic metastases
* Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
* Hypersensitivity to darbepoetin alpha, to r-HuEPO or their components
* Uncontrolled hypertension.
* Inability to provide informed consent.
* Inability to comply with follow-up
Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study

The main objective of the study is to evaluate the improvement in quality of life after deep brain stimulation surgery with frameless technique by comparing the PDQ-39 scale score at baseline (before surgery) and one year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria;
* patients who are candidates for deep brain stimulation intervention, according to the international criteria of the "Core assessment program for surgical interventional therapies in Parkinson's disease" (CAPSIT-PD).

Exclusion Criteria:

- patients unable to give informed consent.
Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)

In cancer patients, pain is one of the most common symptoms. The range of reported prevalence of pain varies from 33% to 64% including different stages of cancer, during or after anticancer treatment. Moreover, despite the optimal management of basal chronic pain, 66% of these patients have reported breakthrough pain which has a severe impact on quality of life. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in medical oncology services according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain in medical oncology services as well as other factors that can affect quality of life. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in medical oncology services in Spanish hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Patients with histologically confirmed neoplasia
* Patients attended in medical oncology consultations
* Life expectancy \> 3 months
* Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm
* Written informed consent

Exclusion Criteria:

* Untreated patients with opioids for baseline pain
* Patients who are not opioid tolerant
* Serious psychiatric disorder or any disease or condition that prevents the collection of data
* Patients with evidence of opioid addiction or history of drug or alcohol abuse
Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study

The purpose of this pilot feasibility study is to provide continued CGM access to youth with type 2 diabetes and collect descriptive data about feasibility of use of CGM in youth with type 2 diabetes ages 4 years and older. From this study the investigators hope to learn if CGM use in youth with type 2 diabetes can be tolerated and sustained with good adherence and to describe blood glucose patterns in youth with type 2 diabetes. The primary aim will be to evaluate the feasibility of CGM start and continuation in youth with T2D and describe glucose metrics and patient reported outcomes (PROs). The investigators will pilot and refine a program to test the hypothesis that CGM start and continuation in youth with T2D is feasible and then evaluate glucose metrics and PROs.


Eligibility Criteria:
Inclusion Criteria:

* public insurance
* between ages 4-19.99 years inclusive
* diagnosis of T2D (diabetes autoantibody negative) followed in the Pediatric Endocrinology clinic at Stanford Children's Health
* HbA1C greater than 6.5% at enrollment
* interested in starting on a continuous glucose monitor
* have access to a mobile device that is compatible with CGM applications or willing to use CGM receiver provided

Exclusion Criteria:

* non-T2D diagnosis
* HgA1C \< 6.5%
* are not willing to wear CGM
* have private health insurance.