cyrilzakka/clinical-trials huggingface dataset:
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease

A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis

The investigators hypothesize that adults with sickle cell disease (SCD) and osteonecrosis of the femoral (hip) and/or humeral (shoulder) heads will tolerate oral alendronate 70 mg administered once a week x 24 weeks (6 months). In addition to collecting safety and tolerability data on alendronate in study participants, the investigators will also measure the preliminary efficacy of alendronate using changes in the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact scores from baseline to 3-months and 6-months after alendronate initiation. Serum and urine specimen will also be collected to assess changes in bone biomarkers at baseline, 3-months, and 6-months.

The investigators plan to recruit 24 adults with SCD from the University of California Davis Medical Center to this single-arm, open label, interventional study. The investigators anticipate enrolling 1-2 participants per month between Sep 2024- Dec 2025.

The study endpoints are summarized below:

* To determine the recruitment and retention rates of adults with SCD and osteonecrosis enrolled in this prospective, single-arm, open label alendronate interventional study
* To measure the safety, tolerability, and preliminary efficacy of oral alendronate in adults with SCD-related osteonecrosis over a 6-month treatment duration
* To measure changes in bone biomarkers in the serum and urine of study participants not receiving chronic red blood cell transfusions at 3 time points: baseline, 3-months, and 6-months after initiation of alendronate

The investigators' goal is to complete primary data analysis by May 2026.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years with SCD (any genotype, confirmed by hemoglobin electrophoresis or high performance liquid chromatography)
* Ability to provide written informed consent
* Ability to lay on a dual-energy X-ray absorptiometry (DXA) scanner
* Negative urine pregnancy test for anyone of childbearing potential at study entry

Exclusion Criteria:

* Pregnant women
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Hospitalizations (for any cause) within 2 weeks of study entry
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets

In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. One is the current formulation and the other one is a new formulation of semaglutide. Both will be administered as a tablet and are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. The tablet version of the study medicine is a new medicine that cannot yet be prescribed. Participants will either get semaglutide in the current tablet formulation previously tested in many large studies, or get the tablet that contains semaglutide in a new formulation - which treatment is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment in a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
* Use of tobacco and nicotine products, defined as any of the below:
* Smoking more than 5 cigarettes or the equivalent per day
* Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s)
* History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
* Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject).
* History (as declared by the subject) or presence of pancreatitis (acute or chronic).
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders

This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.


Eligibility Criteria:
Inclusion Criteria:

* Avoidant or Borderline personality disorders

Exclusion Criteria:

* Do not speak Scandinavian languages
* Antisocial personality disorder
* Narcissistic personality disorder
* Affective bipolar disorder I
* Schizophrenia
* Mental impairment/organic brain disorder
* Substance dependence
* Planned pregnancy
* Serious somatic illness
* Anorexia Nervosa
Efficacy of Arch Insoles in the Dynamic Postural Control for the Elderly

The purpose of this study is to measure the ability of balance controlling and test the evaluation of clinical trials with different arch insoles. The investigators want to find out the difference and efficacy of arch insoles in the dynamic postural control for the elderly.


Eligibility Criteria:
Inclusion Criteria:

* no cognition problem. (mini-mental state examination \[MMSE\] \> 23)
* no sensory or motor problem
* no use drugs about balance control
* lower extremity without any traumatic injury

Exclusion Criteria:

* Cognition impairment
* with specific neurological deficits resulting from neuropathy, neuromuscular disorders or spinal stenosis
* use drugs about balance control
* total joint arthroplasty
A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel

Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.


Eligibility Criteria:
Inclusion Criteria:

* HIV-negative
* Willing to participate and sign an informed consent
* Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
* Willing to use two forms of contraception during the study.
* Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
* Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses.
* Willing to abstain from using any vaginal product (other than the study product or placebo).
* Willing to be sexually abstinent from randomization until completion of Day 7 evaluations.

Exclusion Criteria:

* Currently pregnant or breast-feeding.
* Clinically detectable genital abnormality on the vulva, vaginal walls or cervix.
* Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed genital ulcer disease or active HSV-2 lesions.
* Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization.
* Symptomatic bacterial vaginosis and unwilling to undergo treatment.
* Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
Study for the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.

Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.

The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Eligibility Criteria:
Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable / uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance
Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice


Eligibility Criteria:
Inclusion Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

* Male or female aged 2 to 40 years
* Confirmed pathological diagnosis of newly-diagnosed, nonmetastatic, resectable, primary, high-grade osteosarcoma
* Have completed definitive surgery (or other local ablation technique)
* Have a treatment regimen that includes mifamurtide and a minimum of 2 recognized chemotherapy agents in the treatment of osteosarcoma (cisplatin, doxorubicin, high-dose methotrexate or ifosfamide)
* Organ function deemed satisfactory to receive planned chemotherapy containing at minimum 2 of the recognized chemotherapy agents in the treatment of osteosarcoma
* Voluntary Written Consent

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

* Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period
* History of pericarditis or pleuritis
* Have low-grade osteosarcoma or parosteal or periosteal sarcoma
* Have osteosarcoma associated with Paget's disease
* Current treatment with any anticancer investigational products at the time of enrollment in this study
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair

The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery.

This study is a non-interventional, multicenter and post market clinical follow-up in adult women with apical prolapse under normal conditions of use (after a sacrocolpopexy with Restorelle mesh for apical prolapse repair as part of routine care). The patient will be followed for 1 year (or less) by the investigator as per local usual practice. At the same time, the patient will be followed via PRO (Patient Reported Outcomes) over a period of 5 to 8 years.

Eligibility Criteria:
Inclusion Criteria:

* Female patient of at least 18 years old
* Patient presenting apical pelvic organ prolapse and being eligible to surgical treatment
* Surgeon having decided to treat the patient with a Restorelle mesh as per its CE mark indication and IFU, before patient inclusion
* Patient having received appropriate information and counselling before mesh implantation
* Patient has been provided written informed consent

Exclusion Criteria:

* Patient currently pregnant or breastfeeding
* Patient being deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection
A Mobile Application for Training of Family Caregivers Caring for Someone With Dementia

Background

The mental, physical, and emotional health of caregivers is negatively affected by the burden of caring for of persons living with dementia. Caregivers are usually reported as feeling frustrated, angry, exhausted, guilty, helpless and unable to bear the heavy burden of their caregiving responsibilities. In addition to depressive symptoms and other mental health problems among caregivers, the physical stress of caring for someone who is unable to perform daily activities such as bathing, grooming and other personal care, has been shown to be a serious threat to caregivers' physical health outcomes. Evidence has shown that greater levels of stress, anxiety, depression, frustration, and lower subjective well-being and self-efficacy are exhibited in a greater amount among family and friends who care for persons living with dementia compared to those who do not have the burden of caring for a persons living with dementia. Caregivers have been shown to use alcohol and other drugs at a higher rate than those who do not need to care for others as a reaction to this increased stress. Studies has also shown that caregivers are more likely than non-Caregivers to use opioid or psychotropic medications. One over five caregivers (22%) feel tired when they go to bed at night.

Objectives

This study relies on a mobile application (Caring4Dementia) that provides people, caring for a person living with dementia, with a useful and intuitive training tool targeting communication skills. The aims of this study are to evaluate the feasibility and acceptability of using Caring4Dementia within a self-administered program and the preliminary efficacy of the Caring4Dementia intervention.


Eligibility Criteria:
Inclusion Criteria:

* Informal caregiver of a person living with dementia for more than 6 months
* Able to read and understand English
* Able to use smartphones and tablets (Apple or Android)
* Have a smartphone or tablet (Apple or Android) with internet connection, involved in this study
* 18 years or over
* Give written and oral informed consent

Exclusion Criteria:

* None
Optimizing Treatment of Stage IV Breast Cancer Through Real-Time Disease Monitoring

This study evaluates if blood tests can detect changes in disease status during treatment for stage IV breast cancer. Information from this study may help researchers learn more about metastatic breast cancer and how to optimize treatment.

PRIMARY OBJECTIVES:

I. To identify subtype-specific signatures for breast cancer using genomic positioning of plasma deoxyribonucleic acid (DNA) fragments.

II. To validate changes in circulating tumor-derived DNA (ctDNA) levels as a biomarker for treatment monitoring in patients with metastatic breast cancer.

OUTLINE:

Patients undergo collection of blood samples at baseline, 2 weeks after the start of treatment, and at the beginning of each new treatment cycle.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years of age
* Stage IV breast cancer undergoing cancer treatment

Exclusion Criteria:

* Stage I-III breast cancer
* Unwilling or unable to give consent
* Patients with a prior or concurrent malignancy, excluding non-melanoma skin cancers and non-invasive cancers whose natural history or treatment does not have the potential to interfere with the assessment of the investigational marker
Comparison of Er,Cr:YSGG and Diode Lasers In Second Stage Implant Surgery

The study evaluates postoperative pain, intraoperative bleeding and wound healing after second stage implant surgery. Submerged implants were exposed with diode laser in Group 1 (n=20) and by using Er,Cr:YSGG laser in Group 2 (n=20).


Eligibility Criteria:
Inclusion Criteria:

* subject has osseointegrated implants embedded under oral mucosa.
* subject undergoes second-stage implant surgery.

Exclusion Criteria:

* inadequate keratinized gingiva in the implant site.
* localization of the implant site is not possible due to excessive thickness of the oral mucosa
Umbilical Cord Milking in Non-Vigorous Infants

The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.

At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems.

The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Non-vigorous newborns born between 35-42 weeks gestation

Exclusion Criteria:

* Known major congenital or chromosomal anomalies of newborn
* Known cardiac defects other than small ASD, VSD and PDA
* Complete placental abruption/cutting through the placenta at time of delivery
* Monochorionic multiples
* Cord anomaly (i.e. cord avulsion, true knot)
* Presence of non-reducible nuchal cord
* Perinatal providers unaware of the protocol
* Incomplete delivery data
* Infants born in extremis, for whom additional treatment will not be offered
Amyloid Accumulation After Mild Traumatic Brain Injury

There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago and GCS=13-15 will be recruited. Another group of 200 participants with the same age and gender and without TBI will be recruited as the controls. All of them will undergo AD8 questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore \>/=2. 10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for AV45 amylid PET study.

There will also be 10 participants without traumatic brain injury and interested in this study, aged 55 years or older better.

We will examine the mTBI patients in a long-term follow-up manner by cognitive tests and A-PET. This is a novel study for linking mTBI and AD by solid, reliable methods, in terms of A-PET and cognitive function tests. In addition, we will figure out the importance of APOE genotypes for amyloid accumulation and cognitive impairment. These results should shed light on the further clinical studies and amyloid-cleaning therapy for prevention and treatment for dementia after mTBI.

Eligibility Criteria:
Inclusion criteria:

* The individuals are listed in the Taipei medical university traumatic brain injury databank and had TBI in 1, 5, 10 and 15 years ago. There are about 200 individuals undergo telephone interview/invitation, blood test for genotyping and neuropsychological tests. 30 participants will be selected randomly among the 200 individuals.
* mild injury in TBI (initial GCS = 13-15)
* had MRI or CT evaluation after TBI
* aged 30 years or older better
* agreed by principal investigator
* have agreement and have signed the informed consent form by him/herself or his/her legal representative

Main exclusion criteria:

* participating in another clinical trials which might interfere the current finding.
* not sure the timing of TBI
* contaminant the symptoms with injury, skull fracture, intracranial hemorrhage, craniotomy, and death
* moderate (initial GCS = 9-12) or severe (initial GCS \< 8) injury in TBI
* had wound with gunshot or puncture
* loss of consciousness over 30 minutes after TBI
* loss of memory for over 1 day after TBI
* have no MRI or CT evaluation of brain after TBI or have obstructive ischemia after MRI or CT evaluation
* have uremia, liver cirrhosis, heart failure, pulmonary edema, coagulation disorders and other major diseases
* pregnant woman or emotional instability
* the age less than 18 years (30 years better)
* unable to collect blood sample by peripheral vein
* determination of inappropriate participants in the clinical trail of PI