cyrilzakka/clinical-trials huggingface dataset:
Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.


Eligibility Criteria:
Inclusion Criteria:

* 1. signed the informed consent
* 2. ≥18 years old
* 3. confirmed as malignant solid tumor by histopathology or clinical judgment
* 4. Patients will undergo 18F-FDG PET/CT examination

Exclusion Criteria:

* 1. Known allergy to components of the investigational drug or its analogues
* 2. suspected to have a certain disease or condition that is not suitable for the study drug
* 3. Known pregnant or lactating women
Postnatal mHealth Intervention Development

This study is a six-week exploratory developmental phase (phase 1) of a larger project to develop an mHealth intervention targeting health education and social support for Indian women in the postnatal period. Phase 1 of the trial exposes study participants to various intervention modalities and seeks to understand their experiences and perspectives on these using mixed-methods. Results from this trial will inform modifications to the intervention to be tested in Phase 2.

Most mHealth interventions for maternal and child health (MCH) in low and middle-income countries, including India, have focused on unidirectional and non-interactive approaches, primarily text messaging. However, ample evidence suggests that provider-led, interactive educational programming and social support are key for improving health behaviors and outcomes. Thus innovative mHealth approaches that promote interactive education and facilitate social support have great potential to improve MCH outcomes. The two-phase development of MeSSSSage will include Phase 1: exploratory development on functions and platforms and Phase 2: a mixed-methods randomized pilot study using a factorial design of specific intervention functions and platforms confirmed in Phase 1. Study activities described herein are associated with Phase 1. The study's specific aim is: To develop optimal intervention functions, processes, and mHealth platforms for education and peer support among postnatal women in rural India. In Phase 1, the investigators will explore potential interactive education and peer support group intervention functions (education, emotional support, instrumental support, referrals, linkages, follow-up on postnatal visits), processes (group interactions; frequency, length and timing of groups; engagement opportunities, participant profiles) and mHealth delivery platforms (voice, text chat, app options, interaction features). This six-week developmental component will include up to four groups (n=48; 12 per group) to assess different modalities and functions. The investigators will ascertain women's preferences for functions, processes, and platform features using survey and in-depth interviews (IDIs), and capture levels of engagement via back-end data. This process will also inform the intervention's health information content. Findings will be used to formalize the group mobile intervention details to be examined in Phase 2.

Eligibility Criteria:
Inclusion Criteria:

* Postnatal (within 2 weeks)
* 18+ years old

Exclusion Criteria:

* Women below 18 years of age
* Women with high risk pregnancies
* Women who delivered preterm, suffer severe maternal complications or they or their baby are otherwise sick in the first week
Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome

This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment.

The hypothesis is that vitamin D supplementation results in significant improvement in the ovulation rate of women with PCOS either spontaneously or with oral ovulation induction agent.

Anovulatory women with PCOS diagnosed by the Rotterdam criteria will be recruited.

Participants will be randomized to the (1) vitamin D group or (2) placebo group. Those in the vitamin D group will take vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000IU once every 2 weeks for 52 weeks, whereas those in the placebo group will take placebo tablets with the same external appearance. Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.

The primary outcome is the ovulation rate and will be compared between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Aged 18-40 years
* Irregular long menstrual cycles (\>35 days)
* PCOS according to the Rotterdam criteria
* Agree for transvaginal ultrasound

Exclusion Criteria:

* Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months
* History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
* Use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive
* Anticipated to use the above medications in the coming one year
* Known type 2 diabetes mellitus
* Refusal to join the study
* Abnormal blood calcium level

For those on supplements, we asked them to stop their own supplements.
MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE

The aim of this study is to evaluate the monitoring of moderate diabetic retinopathy by tele-expertise

This study compares 2 strategies of monitoring of moderate diabetic retinopathy (RD).After a consultation with an orthoptist for measurement of visual acuity, measurement of ocular tone by pulsed air tonometer, retinography pictures (9 photographs: one of the posterior pole and 8 of the retinal periphery) and Optical Coherence Tomography (OCT), results are evaluated on-site by an ophthalmologist and then sent through a secure medical online application to an ophthalmologist expert in RD for assessment. Each patient is his own control.

Eligibility Criteria:
Inclusion Criteria:

* patient with complicated diabetes mellitus with moderate retinopathy

Exclusion Criteria:

* Patient deprived of liberty by judicial or administrative decision
* Person subject to a legal protection measure
* Patient already involved in another clinical trial protocol
Time Restricted Feeding for Weight Loss and Cardio-protection

Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. TRF is effective for weight loss and cardio-protection in obese adults. It is of great interest to see whether subjects can adhere to TRF for longer periods of time, and to see what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers.

Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. Recent findings from short-term uncontrolled trials suggest that TRF is effective for weight loss and cardio-protection in obese adults. In view of these pilot findings, it is of great interest to see whether subjects can adhere to TRF for longer periods of time, and to see what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers. To test the study objectives, a 14-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline; and (2) 12-week weight loss, will be implemented. Obese subjects (n = 40) will be randomized to 1 of 2 groups: (1) TRF (n = 20), or (2) control (n = 20). This study will be the first randomized controlled trial of TRF, and will show that TRF can be implemented to help obese individuals lose weight and lower risk of coronary heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Body mass index (BMI) between 30.0 and 40 kg/m2
* Age between 25 and 65 years
* Sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week)
* Weight stable for \>3 months prior to the beginning of the study (gain or loss \<4 kg)
* Able to give written informed consent

Exclusion Criteria:

* Smoker
* Diabetic
* History of cardiovascular disease (myocardial infarction or stroke)
* Taking weight loss medications
* History of eating disorders
* Night-shift workers
* Perimenopausal
* Pregnant or trying to become pregnant
Denosumab Versus Bisphosphonates (Alendronate) in GIOP

A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis

Study design: an open-label randomized controlled trial Duration of study: 12 months

Treatment arms:

1. Denosumab: a total of 2 doses in a period of 12 months
2. Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)

Eligibility Criteria:
Inclusion Criteria:

1. Adults (women or men) \>18 years of age
2. Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
3. Informed consent from patients.
4. Willing to comply with all study procedures

Exclusion Criteria:

1. Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
2. Premenopausal women who plan for pregnancy within 18 months of study entry.
3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
4. Patients with unexplained hypocalcemia.
5. Patients with serum creatinine level of \>=200umol/L.
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants


Eligibility Criteria:
Inclusion Criteria:

* Participants must be ethnically Japanese (both biological parents are ethnically Japanese).
* Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study.
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of splenectomy).

Other protocol-defined inclusion/exclusion criteria apply.
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

The primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation.

The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months. Acquisition of auditory milestones and speech recognition skills, which underpin the development of spoken language, will be assessed on a battery of outcome measures typically used to quantify implant benefits. In addition, global quality of life and communicative performance will be assessed by parental proxy. Performance will be tracked after 3, 6, 12, 18, and 24 months of device use. The study also will identify variables that may predict the degree of bilateral implant benefit in young children (e.g., age at implant, pre-implant hearing thresholds, communication mode, family socioeconomic status, post-implant aided thresholds, simultaneous vs. staged placement of devices).

Eligibility Criteria:
Inclusion Criteria:

* Profound bilateral hearing loss (PTA\>= 90dB HL)
* Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System and meet all the eligibility criteria for this device as described in the product labeling.
* Age at implant: 12-36 months
* Negligible benefit from hearing aids, defined as failure to reach developmentally appropriate milestones on IT-MAIS
* No previous cochlear implant use
* Normal/patent cochlea with no more than a mild "partitioning" defect in either ear
* English as the primary language spoken in the home
* Parental willingness to follow study protocol

Exclusion Criteria:

* Deafness secondary to meningitis
* Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation of outcomes measures.
Effect of EEG-guided General Anesthesia on Cumulative Dose of Norepinephrine

Intraoperative hypotension is common in patients having non-cardiac surgery under general anesthesia and is associated with major postoperative complications including myocardial injury, AKI, and death.

Intraoperative hypotension is also common in patients having vascular surgery. To treat intraoperative hypotension, vasopressors - such as norepinephrine - and fluids are used. However, high-dose vasopressor and excessive fluid therapy are also associated with postoperative complications.

The depth of general anesthesia may be a modifiable cause of intraoperative hypotension. Deep levels of general anesthesia may cause cardiovascular depression with intraoperative hypotension and higher vasopressor requirements. Optimal depth of general anesthesia is defined as a state in which the patient is at low risk of recall of intraoperative events while maintaining blood pressure stability with minimal intervention.

Depth of anesthesia can be confirmed using clinical signs, the concentration of inhaled or intravenous anesthetics, or neuromonitoring such as processed electroencephalography (pEEG). pEEG presents an opportunity to monitor changes in human brain electrical activity and to help estimating the patients' level of (un)consciousness and the optimal depth of anesthesia. EEG-guided general anesthesia may thus decrease norepinephrine doses needed to treat intraoperative hypotension in patients having surgery.


Eligibility Criteria:
We will include consenting patients ≥45 years scheduled for elective vascular surgery under general anesthesia if:

* surgery is expected to last at least 60 min AND
* the estimated blood loss during surgery is less than 1000 mL AND
* intraarterial blood pressure monitoring (arterial catheter) is planned during surgery

We will not include patients with previous transplantation of kidney, liver, heart, or lung and those who are septic (according to current Sepsis-3 definition). And we will not include patients with American Society of Anesthesiologists' physical status V and VI, or pregnancy.

We will exclude patients after randomization if they were treated with vasopressors others than norepinephrine during surgery.

Written informed consent will be obtained from all patients prior to study inclusion.
Interleukin-2 in Metastatic Melanoma

To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage

In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (\> 1440 million IU/m2/year).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated.
2. Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
4. White blood count of \> 3500/mm3, platelet count \> 100,000/mm3, hemoglobin \> 9.0 gm/dl; bilirubin, ALT, AST \< 3 x upper limit of normal; serum creatinine \< 2.0 mg/dl.
5. Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
6. Patients with elevated temperatures \> 100.5 F must have sources of occult infection excluded.
7. Patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy.
8. Patient consent must be obtained prior to entrance onto study.
9. Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment

Exclusion Criteria:

1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
4. Lactation or pregnancy.
5. Evidence of significant cardiovascular disease including history of recent (\< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
6. Current brain metastasis.
Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria

Study of the efficacy and safety of aliskiren when added to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension
* Elevated urinary protein levels
* Confirmed type 2 diabetes

Exclusion Criteria:

* Certain diseases
* Uncontrolled diabetes
* Type 1 diabetes
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients

The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.


Eligibility Criteria:
Inclusion Criteria:

* Presence of MCI defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss.
* Absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years.
* Able to give written informed consent.
* Age \>/= 60 years of age
* \>/= 7 years of education

Exclusion Criteria:

* Mini mental state examination (MMSE) score \< 24 at baseline
* Clinical dementia rating (CDR) score \> 0.5 at baseline
* Patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics)
* Existing or history of cancer
* History of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion
* Lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder
* Contraindications to MRI (Magnetic resonance imaging)
* Relevant history, physical or imaging findings of neurological disease other than MCI and mild depression
* History of severe anaphylactic reaction or high risk of allergic reaction to drugs
* Patient has received another investigational drug in the preceding 14 days
Electromyography of the Pectoral Muscle in Mastalgia Patients

Mastalgia is a common problem for women. The aim of this study is to investigate the role of neuromuscular pathologies of the thorax wall at mastalgia ethiopathogenesis.

Mastalgia is a common health problem for women especially these days. Studies demonstrated that 48% of the women with mastalgia have serious difficulties in their sexual life, 36% have physical activity difficulties, 13% have social activity difficulties and 6% have work or school activity difficulties. The etiology of the mastalgia is not clear. Because of the women with mastalgia tested out lots of examinations for the etiology. Also this problem has financial load because of the unknown etiology.

Eligibility Criteria:
Inclusion Criteria:

* Subject has unilateral mastalgia

Exclusion Criteria:

* Subject has pregnancy
* Subject has breast cancer
* Subject has a history of breast operation
* Subject has diabetes mellitus
* Subject has 1 cm or above cystic or solid lesions in the breasts.
A Clinical Trial of a New Computer Based Intervention for Children With Autism.

The CLICK-EAST research project is an investigation of the efficacy of a computer based learning programme which aims to teach the fundamental components of social attention to young children with autism spectrum disorder (ASD). "Social attention" describes the process of choosing to look at or listen to social information in the world, normally in preference to any other available information. Social information normally refers to people: for example, we notice human voices more than birdsong or traffic noise, even if the latter is louder. As a rule, children with ASD are less likely to prioritise this kind of social information. This is thought to have a significant effect on their development and behaviour. For example, a child who doesn't listen to what his parents say may be very slow to learn language, and may also fail to follow important instructions. Our goal is to create a new learning programme, in the form of an enjoyable computer game, which encourages children to practise the skills of looking at and listening to people, despite the presence of distracting information. The investigators will develop the game with the input of an advisory group of parents and teachers of children with ASD as well as some young adults with an ASD diagnosis. Then they will perform a trial of the game with a group of preschoolers with ASD and their families, in order to determine whether the game is having a positive effect on the children's abilities.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of core autism
* aged between 15 months and 5 years, 11 months.
* minimum nonverbal age equivalent of 15 months.

Exclusion Criteria:

* Children with epilepsy whose developmental progress may be impeded
* families with little knowledge of the English language such that their understanding of the information sheets and instructions accompanying the trial is limited. Unfortunately funding is not available for the provision of translators or translated materials.