cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial of a Video Decision Aid in the ICU

Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.


Eligibility Criteria:
Inclusion Criteria:

- Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge

Exclusion Criteria:

- Patients who are imminently dying and admitted to the ICU are excluded Wards if the state
Mechanistic Studies of Psilocybin in Headache Disorders

In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.


Eligibility Criteria:
Inclusion criteria:

* Age 21 to 70 (inclusive)
* Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient

Exclusion criterion

* Unstable medical condition or serious nervous system pathology
* Pregnant, breastfeeding, lack of adequate birth control
* Psychotic or manic disorder
* Substance abuse in the prior 3 months
* Use of classic psychedelics (e.g., psilocybin, LSD, mescaline) in the past 6 months
* Use of cannabis or other THC products in the prior 2 weeks
* Urine toxicology positive to drugs of abuse
* The use of triptans (e.g., sumatriptan) or ditans (e.g., lasmiditan) more than twice weekly on average
* Use of serotonergic preventive therapies (i.e., taken chronically; amitriptyline, fluoxetine, imipramine, cyproheptadine) in the past 6 weeks
* Use of preventive or transitional treatments that produce spikes and waning of symptom relief (e.g., botulinum toxin, calcitonin gene-related peptide system targeting antibodies, peripheral nerve or ganglion blocks, chiropractic manipulation)
* History of a bleeding disorder or are currently taking anticoagulants (e.g., warfarin, enoxaparin, dabigatran, apixaban).
* Use of non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen) in the 7 days before PET scan and 7 days after PET scan.
Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique

In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* WHO performance status 0-2.
* Invasive breast cancer or ductal carcinoma in situ (DCIS).
* Stage I-III breast cancer or DCIS.
* Treated with curative radiotherapy of the breast (as part of breast conserving therapy) with simultaneous integrated boost technique, with or without irradiation of the regional (including internal mammary) lymph nodes.

Exclusion Criteria:

* Previous thoracic radiotherapy.
* Previous history of malignancy, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
* Bilateral (synchrone) invasive breast cancer.
* Treatment prior to surgery (i.e. neoadjuvant chemotherapy, neoadjuvant hormonal therapy, pre-operative radiotherapy).
* Distant metastases at diagnosis (M1).
* Unsufficient knowledge of Dutch language.
Oxygen Reserve Index for Kids

In infants less than two years old the new Oxygen Reserve Index (ORI) will be measured during general anaesthesia. It will evaluated if and how ORI-monitoring gives earlier warning of hypoxaemia than conventional oxygen saturation measurement.

The Oxygen Reserve Index (ORI) is a new development in multiple wavelength pulse oximetry, reflecting the arterial partial oxygen pressure (PaO2) continuously and non-invasively by an index. In contrast to established standard oxygen saturation (SpO2) measurements, ORI detects a drop of PaO2 until the threshold of 100 mmHg. During anaesthesia induction-associated apnoeic periods ORI may detect a drop of PaO2 early enough for the anaesthesiologist to interrupt the intubation procedure and re-start oxygenation. In contrast, due to the flat upper part of the oxyhaemoglobin dissociation curve, SpO2 stays at values above 90% until PaO2 falls below 60mmHg. At this point, SpO2 drops rapidly and a pro- longed hypoxic dip is the consequence. To avoid this potentially harmful hypoxic dip, continuous monitoring of PaO2 using ORI would be advantageous during anaesthesia induction phase.

This clinical study aims to evaluate the time benefit between alarm of hypoxaemia by the ORI-monitoring and the start of the dropping of oxygen saturation. Pre-set and pre-described ORI-alarms will be checked for their utility and a new ORI-alarm will be defined that is potentially more useful. As secondary endpoints the study examines the correlation of ORI with PO2, the influence of patient or measurement characteristics on the correlation of ORI with PO2 and the influence of the measurement site on ORI-measurement.

Eligibility Criteria:
Inclusion Criteria:

* small infants \< 2 years scheduled for elective surgery with general anaesthesia.

Exclusion Criteria:

* emergency procedures, lack of informed consent of legal guardian
Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation

Goals of the study :

1. To study maternal thyroid function during pregnancy with or without supplementation with pregnancy tablets fortified with iodine
2. To establish reference values of thyroid function at different stages of pregnancy (3 trimesters)
3. To precise screening strategy of iodine deficiency in our population and suggest recommendation for its prevention.

Overt maternal hypothyroidism and/or iodine deficiency during pregnancy are linked to mental retardation in their offspring. Iodine deficiency may lead to maternal hypothyroxinemia, and even mild hypothyroidism in predisposed women. Indeed, thyroid hormones are of paramount importance for fetal brain development. During the first trimester of pregnancy, the only thyroid hormones available to the fetus are from maternal origin. Later in pregnancy, fetal thyroid progressively starts producing thyroid hormone, providing that maternal iodine status is adequate (≥200-250 mcg/day). It has been shown recently that mild maternal hypothyroidism may be responsible for discrete neuropsychological impairment in her child, implying a potential benefit for early screening and care during pregnancy. Furthermore, iodine deficiency is extremely common in our area (Brucker-Davis et al 2004). However, there is no official recommendation for screening and prevention, as for gestational diabetes for example.

We propose to study healthy pregnant women, screened before 12 weeks of gestation and without thyroid disease. They will be randomized in 2 groups and will therefore take pregnancy tablets, iodine fortified or not (Oligobs Maxiode -150 mcg/j of iodine, vs Oligobs grossesse), in addition to appropriate nutritional advice. Their longitudinal study will involve:

1. Evolution of thyroid function parameters in the 2 groups, with comparison of maternal thyroid volumes, maternal thyroid hormones levels and cord blood parameters, including thyroglobulin, during pregnancy and in postpartum.
2. Establishment of reference ranges for thyroid parameters for each trimester of pregnancy.

This public health project rests on our expertise in the care of pregnancies with maternal endocrine and metabolic disease (Hieronimus et al 2003-2005) and on a close collaboration of our Departments within the Pole "Mother-Child", conveniently located at the same hospital. It will allow us to precise iodine deficiency screening and prevention in our population and to structure and optimize the care for women with thyroid disease screened early in pregnancy (opening of a specific clinic), in order to improve maternal and fetal prognosis

Eligibility Criteria:
Inclusion Criteria:

* All women follow-up in the three months of the pregnancy in the CHU de Nice
* Maternal thyroid function is between and 0.1\<TSH\<2.5 mUI/l, 23\>T4L\>12 pmol/l
* Person over 18
* Signed lit Consent
* Give birth in the CHU of Nice

Exclusion Criteria:

* Allergy known in iodine
* Iodized surcharge defined by an iodurie\> 400 mcg / l
* Catch of ongoing iodized vitamins of pregnancy
* Participation in another research protocol
Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis

To test the effects of 6 month additional intervention of ORIENT diet versus usual medical treatment for Intracranial / Carotid Stenosis on cognitive decline, multi-mode MRI image markers and serum and fecal biomarkers in a randomized controlled trial of 120 patients with intracranial / carotid stenosis, who are aged older than 40 years and without dementia.

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet in Patients With Intracranial / Carotid Stenosis is designed to test the impact of a 6-month intervention utilizing a culturally adapted version of the MIND diet, named as the ORIENT diet, on 120 older patients (aged 40 years and above and without dementia) diagnosed with intracranial/carotid stenosis (defined as ≥ 50% stenosis in unilateral intracranial/carotid artery as detected by vascular imaging diagnostic techniques, such as magnetic resonance angiography). The ORIENT diet retains the core components of the DASH, Mediterranean, and MIND diets, but incorporates adjustments according to evidence derived from Asian prospective cohorts and Chinese dietary practices. Participants in the intervention group will receive standard medical treatment in conjunction with the ORIENT diet intervention, while those in the control group will undergo standard medical treatment and receive usual dietary advice. The study's primary objective is to assess the influence of the ORIENT diet on cognitive function and brain macro- and microstructural integrity in patients with intracranial/carotid stenosis. This will be achieved through the administration of neuropsychological assessments and multi-modal magnetic resonance imaging at 6-month intervals until the completion of the trial. The investigation will explore potential mediators and modifiers of the intervention's effects by examining various cardiovascular risk factors, serum and fecal biomarkers, and underlying biological mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 40 years
* ≥ 50% stenosis in unilateral intracranial / carotid artery
* Written informed consent available
* Willingness to complete all assessments and participate in follow-up
* Adequate Visual and auditory acuity to undergo neuropsychological testing

Exclusion Criteria:

* Previous history of major head trauma and any intracranial surgery
* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
* Severe loss of vision, hearing, or communicative ability
* Nuts, berries, olive oil, or fish allergies
* Patients presenting a malignant disease with life expectancy \< 3 years
* Participation in an ongoing investigational drug study

Exit Criteria:

* Not meet the inclusion criteria
* For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
* Any adverse or serious adverse events during the study period judged by Investigator
The Effects of Mass Media Photographs on Drug-Related Stigma

The aim of this study was to evaluate the effects of exposure to drug-related photos used by the media on emotions, stigma towards people who use drugs, and public health services for this population.

This randomized experiment evaluated the impact of drug-related photographs used by the media on stigma towards people who use drugs. A nationally representative sample of US adults was randomized to view different photos used in the media (a person injecting drugs, a person being resuscitated after an overdose, a person receiving treatment, a person in recovery, or a person who had lost a family member to an overdose) and then asked questions about their feelings towards people who use drugs and their acceptance of public health services to address the overdose crisis.

Eligibility Criteria:
Inclusion Criteria:

* participant in existing web-based survey panel (NORC's AmeriSpeak)

Exclusion Criteria:

* not able to complete experiment and survey in English
Quality of Life of Eye Amputated Patients in Denmark

The purpose of this study is to evaluate eye amputated patients health related quality of life, perceived stress, self-rated health, labour marked participation and socio-economic position.

The investigators hypothesis is that quality of life, perceived stress and self- rated health of many eye amputated patients are drastically changed. Eye amputation has a marked negative influence on labour marked participation and socio-economic position of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were operation for evisceration, enucleation, orbital exenteration or secondary implantation of an orbital implant during the period 1996-2003. 267 patients were in 2005 invited to a clinical investigation and of those 173 accepted.
* Included in this study were patients who came to the clinical investigation, who accepted to receive questionnaires and were alive in 2008.

Exclusion Criteria:

* Dead
* Below 18 years
* Left the country
* Living at Greenland or the Faeroe Islands
Perineal Echography in the Delivery Room for the Detection of Anal Lesions

The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (\> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow up
* The patient is delivering her first child; vaginal delivery
* The patient has a minimum stage 2 perineal lesion
* The patient accepts perineal echography

Exclusion Criteria:

* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Cesarien section
* No perineal lesion (intact perineum)
* Emergency situation which hinders screening for anal lesions under good medical conditions
* Previous vaginal delivery
Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy

Ovarian cancer is the most lethal malignancy of the female genital tract. Cytoreductive surgery combined with chemotherapy is the primary treatment for ovarian cancer, and radical tumor resection is an important means to improve the prognosis. However, even after complete tumor resection, 75% of patients with ovarian cancer still recur within 3 years after the initial treatment and eventually die from recurrence. In ovarian cancer, the lesions are located primarily in the peritoneal cavity. High-grade evidence demonstrates that the use of intraperitoneal hyperthermic chemotherapy (HIPEC) with cisplatin after cytoreductive surgery significantly improves the outcome in some patients with ovarian cancer. Currently, this is the only non-pharmacologic treatment that reduces both the risk of recurrence and death from ovarian cancer with a multi treatment. However, HIPEC with cisplatin can lead to acute kidney injury, and a serious complication that can seriously affect the short and long-term prognosis of patients. Sodium thiosulfate has previously been reported to reduce the incidence of acute kidney injury after HIPEC with cisplatin, but this finding has not been confirmed in a high-level study. Therefore, we propose a multi-center, prospective, open-label, randomized, controlled trial including 110 patients with ovarian cancer who received HIPEC with cisplatin, to evaluate whether sodium thiosulfate combined with hydration (55 patients in the trial group) can reduce the incidence of acute kidney injury after HIPEC with cisplatin compared with hydration alone (55 patients in the control group), and to provide high-level evidence for the rationale of using sodium thiosulfate for nephrotoxicity relief in cisplatin HIPEC.


Eligibility Criteria:
Inclusion Criteria:（The following conditions must be met at the same time）

* Patients treated with HIPEC with cisplatin.
* Estimated survival \> 12 weeks
* Age from 18 to 70 years
* Bone marrow reserve was well functioning. Leukocytosis ≥ 3.0×10\^9/L, neutrophilic granulocyte ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, and hemoglobin ≥ 80 g/L.
* Organs work well. AST ≤ 2.5 × ULN, ALT ≤ 2.5 × upper limit of normal(ULN), total serum bilirubin ≤ 1.5 × ULN, and creatinine ≤ 1.5 × ULN
* ECOG score 0-1
* Patients voluntarily sign an informed consent form

Exclusion Criteria:（None of which was eligible）.

* Extensive abdominal adhesions
* HIPEC with Cisplatin for other medical conditions in the last 5 years.
* Receiving other drugs that cause kidney damage.
* Simultaneous use of amifotin for other diseases.
* Any situation of disease instability or potentially impact safety and adherence of patient.
* Chronic or acute nephropathy of any degree or other serious medical complications.
Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer?

The goal of this clinical trial is to test whether sexual intercourse the night after embryo transfer affects thawed embryo implantation rates. Women undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group will abstain from intercourse for the next 48 hours after the transfer. Researchers will compare the ongoing pregnancy rates between the intervention group and the control group.

It is currently unclear whether sexual intercourse the night after embryo transfer, with or without semen ejaculation, is detrimental to thawed embryo implantation rates.

The following study is a prospective, randomized, clinical trial, including patients attending our university-affiliated Infertility and IVF center.

The goal of this clinical trial is to test whether coitus the night after embryo transfer affects thawed embryo implantation rates. At the day of the embryo transfer women (ages 18-41yrs) undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group is subjected to abstain for the next 48 hours after the transfer.

The day after the embryo transfer an electronic questionnaire will be sent to the patients to confirm whether they had intercourse or not. The questionnaire will also address whether male ejaculation was performed intravaginally and whether female orgasm occurred.

12-14 days after the embryo transfer a BHCG serum test will be performed. For those patients with a negative BHCG test surveillance will be stopped. For those with a positive BCHG test a gynecologic US will be performed at week 6. After wards surveillance will cease for all participants. Researchers will compare the ongoing pregnancy rates between the intervention group and the control group.

Eligibility Criteria:
Inclusion Criteria:

1. Women age 18-41yrs.
2. BMI (body mass index) of 18-35 kg/m².
3. Patients undergoing one of their first four frozen embryo transfers.
4. Patients transferring a good quality embryo, either a cleavage stage embryo or a day 5 blastocyst.

Exclusion Criteria:

1. Patients age above 42.
2. Moderate or poor-quality embryos.
3. Patients with hydrosalpinx or uterus malformations.
4. Patients who are not able or are not interested in having vaginal intercourse (same sex couples for example).
5. Couples undergoing preimplantation genetic diagnosis when natural cycle frozen embryo transfer is planned (as they are instructed to avoid intercourse).
Use of Ranibizumab With Mitomycin C During Trabeculectomy

The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.

A common problem after undergoing trabeculectomy surgery to create a bleb (blister or bubble) to reduce intraocular pressure, is scarring of the opening. This scarring prevents fluid drainage and interferes with the proper functioning of the bleb. MMC (Mitomycin C) is usually administered intraoperatively, to reduce scarring and increase filtration. However, the failure rate of trabeculectomy remains high. Anti-VEGF (Vascular endothelial growth factor) agents have been used successfully in cases requiring bleb needling. The purpose of the study is to determine the safety of the combination of ranibizumab and MMC vs monotherapy MMC in patients with glaucoma.

This is an open-label, Phase I/II safety study of 30 patients randomized to either treatment with ranibizumab 0.5 mg intravitreally injected (n=10), combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) or MMC therapy alone (n=10).

For the ranibizumab groups, a repeat injection of ranibizumab 0.5mg may be given PRN (as needed) at 1 month if hypervascularity or neovascularization of the conjunctiva exists.

Eligibility Criteria:
Inclusion Criteria:

* glaucoma
* undergoing trabeculectomy
* 21 years of age or older

Exclusion Criteria:

* pregnancy or lactation
* any condition the investigator believes would impose a significant hazard to the patient if investigational therapy were initiated
* history of ocular surface disease
* cataract surgery in the past 6 months
* history of active inflammatory, infectious or idiopathic keratitis