cyrilzakka/clinical-trials huggingface dataset:
The Effects of a Multi-ingredient Night-time Tea on Sleep Quality, Wellbeing and Markers of Immune Function

The aim of the study is to determine whether a night-time tea can improve subjective sleep quality in healthy sleepers and self-reported poor sleepers, compared to a control drink.

The study will adopt a randomised, double-blind, placebo controlled, crossover design. Sixty-eight healthy adults aged 18+ (34 good sleepers and 34 poor sleepers) will be recruited from the general population. Good sleepers will be recruited if they have a stable sleep-wake schedule (i.e. bed/wake time within the range of 22.00 - 09.00 and with at least 6.5 hours of sleep duration reported per night). Poor sleepers will be recruited if they report subjective sleep difficulties (i.e. poor sleep quality or unrefreshing sleep) and if they display a Pittsburgh Sleep Quality Index total score of \>5. Participants will consume both an active tea, and a control tea in a counterbalanced order for 7 days (separated by a 7-day washout period). Participants will complete questionnaires assessing mood, quality of life and sleep and provide blood samples to assess immunological markers. Sleep monitoring will also be conducted using actigraphy sleep monitoring and sleep diaries. Assessments will be made at baseline and following 7 days supplementation.

Eligibility Criteria:
Inclusion Criteria:

Healthy male and female adults aged 18 years and above. Both good sleepers and poor sleepers will be recruited. Good sleepers will be recruited if they have a stable sleep-wake schedule (i.e. bed/wake time within the range of 22.00 - 09.00 and with at least 6.5 hours of sleep duration reported per night).

Poor sleepers will be recruited if they report subjective sleep difficulties (i.e. poor sleep quality or unrefreshing sleep) and if they display a Pittsburgh Sleep Quality Index total score of \>5.

Exclusion Criteria:

Both good and poor sleeper participants cannot participate if they display evidence of current or previous sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders); an initial screening for sleep disorders will be conducted using the Sleep Disorders Screening Checklist - 25 (SDS-CL).

* Participants must not be shift workers
* Cannot currently be participating in other research trials which will compromise the results here
* Participants cannot take part if they will be sleeping at a location other than their usual residence during participation
* Nor if they have experienced travel across multiple time zones within the last three months or will be experiencing travel across multiple time zones during the study
* Participants cannot take part if they have current or previous mood disturbances
* Are currently unwell with anything that impacts sleep
* Are currently using medication which affects the central nervous system
* Or are currently misusing alcohol or drugs
Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication.

The pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry.

These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy.

The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.


Eligibility Criteria:
Cohort 1: Tildrakizumab-Exposed Cohort

1. Pregnant women
2. Exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy
3. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records

Cohort 2: Disease-Matched Comparison Cohort

1. Pregnant women
2. Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible
3. No exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy
4. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records

Exclusion criteria:

Cohort 1: Tildrakizumab-Exposed Cohort:

1. Women who have first contact with the project after prenatal diagnosis of any major structural defect
2. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
3. Women who have used tildrakizumab for an indication other than a currently approved indication
4. Retrospective enrollment after the outcome of pregnancy is known

Cohort 2: Disease-Matched Comparison Cohort

1. Women who have first contact with the project after prenatal diagnosis of any major structural defect
2. Exposure to tildrakizumab anytime during the current pregnancy
3. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
4. Retrospective enrollment after the outcome of pregnancy is known
Esprit BTK Post-Approval Study

The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.


Eligibility Criteria:
Inclusion Criteria:

* General Inclusion Criteria

  1. Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site.

     1. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first.
     2. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.
  2. Subject must be at least 18 years of age.
  3. Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
* Anatomic Inclusion Criteria

  1. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm.
  2. Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels.

Exclusion Criteria:

* General Exclusion Criteria

  1. Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).
  2. Subject is currently participating in another clinical investigation.
  3. Subject is unable or unwilling to provide written consent prior to enrollment.
  4. Subject with life expectancy ≤ 1 year.
  5. Subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation.
* Anatomic Exclusion Criteria

  1. Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure.
  2. Subject had been previously treated with Esprit BTK Scaffold(s).
Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine

The purpose of this study was to determine whether clonazepam and paroxetine are effective in the treatment of panic disorder. Efficacy was evaluated in short-term, long-term and post-treatment.

The current study consisted of three steps. The first step was a naturalistic, prospective, randomized, open clinical trial with clonazepam and paroxetine. Subjects received either flexible dose clonazepam (0.5 - 2 mg/day) or paroxetine (10 - 40 mg/day), in monotherapy for eight weeks. In the second step, those who responded to monotherapy in the short-term study continued with the same drug and dose. Partial responders or non-responders were invited to receive combined pharmacological treatment with clonazepam and paroxetine. Patients received the maximum tolerated doses of clonazepam and paroxetine. The doses were flexible, ranging from 0.5 to 2 mg/day for clonazepam and from 10 to 40 mg/day of paroxetine. All patients were treated for 34 months in the second step. Patients who completed the second step and were in remission were included in the third step. For a period of four months all medications were tapered off. These patients were followed for 6 years with evaluations once a year. Those who relapsed were treated on a naturalistic basis, with drugs or psychotherapy.

This study was conducted in accordance with the ethical principles established by the Declaration of Helsinki and the Brazilian National Ethics Committee (Conselho Nacional de Ética em Pesquisa - CONEP) guidelines. The local Ethics Committee approved the study protocol. Written informed consent was obtained from all patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of panic disorder, with or without agoraphobia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text revision (DSM-IV-TR) criteria, as determined by a structured clinical interview.
* At least two panic attacks in the week preceding their inclusion in the study.

Exclusion Criteria:

* Patients unable or unwilling to provide written informed consent.
* Did not complete all the evaluations before study initiation.
* Had comorbidities that could affect clinical evaluation including drug abuse, neurological disorders, or severe personality disorder.
Multi-Center Clinical Trial of Shenling Baizhu Granules for Preventing Low-Risk Colorectal Adenoma Recurrence

The goal of this clinical trial is to learn if Shenling Baizhu granules can prevent colorectal adenoma from coming back in people who had low-risk colorectal adenomas removed. The main questions it aims to answer are:

* Can Shenling Baizhu granules lower the rate of colorectal adenoma returning after removal?
* How safe is Shenling Baizhu granules when used long-term for preventing adenoma?
* Which patients are most likely to benefit from this treatment?

Researchers will compare Shenling Baizhu granules to no treatment to see if the medicine works to prevent adenomas from returning.

Participants will:

* Take Shenling Baizhu granules (6 grams, 3 times daily) or receive no treatment for 6 months each year for 2 years
* Have regular check-ups and provide blood, stool, saliva, and tissue samples
* Get a colonoscopy after 3 years to check if any adenomas have returned
* Fill out questionnaires about their symptoms and overall health throughout the study

This study will include 624 adults aged 18-70 who recently had low-risk colorectal adenomas removed at participating hospitals. The total study duration is 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with low-risk colorectal adenoma
* Complete colonoscopy examination (adequate bowel preparation, cecal intubation, withdrawal time \>6 minutes), with endoscopic resection performed including snare polypectomy, EMR, EPMR, ESD
* Within 1 month after adenoma resection
* Age 18-70 years
* Willing to provide written informed consent

Exclusion Criteria:

* Incomplete adenoma resection
* Long-term use of aspirin, folic acid, calcium, or vitamin D supplements
* Familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch syndrome), or other hereditary polyposis syndromes
* Severe inflammatory bowel disease
* History of malignancy within past 5 years (excluding basal cell carcinoma of the skin and/or cervical intraepithelial neoplasia after surgery)
* Pregnant or lactating women
* Severe cardiovascular disease, cerebrovascular disease, liver or kidney dysfunction, or diabetes
* Severe mental illness that prevents compliance with colonoscopy examination
Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer

This study is being done to see if an experimental drug called recombinant interleukin-21 (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers.

This is a phase 1 safety study. Everyone enrolled and eligible will be given rIL-21. The study has 2 parts, Part A will determine how high a dose of rIl-21 can be safely given to patients with these types of cancers. Part B will determine if the drug is of any benefit to patients with these types of cancers. Part A may have up to 7 different dose groups. Beginning with the lowest dose, 3 patients will be treated and will be watched for side effects. If the side effects are not severe, the next group of 3 patients will recieve a higher dose. This cycle is repeated until the highest tolerated dose group is found.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older with stage 4 metastatic malignant melanoma or stage 4 metastatic kidney cancer
* ECOG status of 0 or 1
* Patients must have adequate liver, kidney and bone marrow function

Exclusion Criteria:

* Known ocular melanoma
* Suspected or confirmed brain metastases
* Patient cannot have had a bone marrow transplant
Muscle Strength Loss In Stroke Individuals - Control Study

ABSTRACT The muscle strength (MS) is necessary to overcome the resistance encountered during the activity. The present study aims to determine MS loss in stroke individuals (SI). 33 SI and 33 healthy individuals (HI) were included in this study. MS and handgrip force were assessed using a power track dynamometer and Jamar hand dynamometer, respectively. The total MS of the HI was calculated by summing the muscle strength of the trunk, lower and upper extremities. In the SI, the muscle strength of the trunk, unaffected upper and lower extremities were summed to calculate the total MS. To compare MS of unaffected sides (US) between groups, 27 SI who was dominant and not affected on the right side and 33 HI who was dominant on the right side were used.


Eligibility Criteria:
Inclusion Criteria:

* for patient with stroke
* Between 30-65 ages
* Diagnosed with stroke chronic stroke patients (diagnosed with a stroke at least 6 months ago)

for healthy individuals

* 30-65 ages
* healthy individuals

Exclusion Criteria for patient with stroke

* patient with an additional neurological disease to stroke
* patients with orthopedic problems,
* patients with mental and communication impairments
* patients who scored more than 3 points for the Modified Rankin Scale for healthy individuals;
* who had active sporting life
A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.


Eligibility Criteria:
Inclusion Criteria:

* be willing and able to sign consent forms;
* be eligible for medical abortion according to clinician's assessment;
* be willing to undergo a surgical completion if necessary;
* have ready and easy access to a telephone and emergency transportation;
* speak English, Spanish, or have a translator available to translate for all study procedures; and,
* agree to comply with the study procedures and visit schedule.

Exclusion Criteria:

* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
* IUD in place;
* Chronic renal failure;
* Concurrent long-term corticosteroid therapy;
* History of allergy to mifepristone, misoprostol or other prostaglandin;
* Hemorrhagic disorders or concurrent anticoagulant therapy;
* Inherited porphyrias; or
* Other serious physical or mental health conditions.
Effects of Switching From Racemic Methadone to R-methadone on QTc Intervals

Effects of switching from racemic methadone to R-methadone on serum methadone concentrations and QTc intervals

Racemic methadone may prolong the QTc interval, which is associated with fatal arrhythmias. In vitro studies have shown that R-methadone has less inhibitory effect than S-methadone on the voltage-gated potassium channel current, and is thus thought to have less effect on the QTc interval.

The investigators hypothesized that switching from racemic to R-methadone would reduce the methadone serum concentration and also its effect on the QTc interval.

Eligibility Criteria:
Inclusion Criteria:

* Stabilized on daily methadone dose
* Not using other drugs of abuse
* QTc-time recorded automatically, patient inclusion if QTc interval was greater or equal to 450 ms
* Older than 18 years
* Can sign and understand a written Consent

Exclusion Criteria:

* Can not cooperate regarding observed daily drug intake
* Serious psychiatric disease
* Untreated serious somatic disease
* Pregnancy
Prevention of Smoking Related Diseases

This is a prospective, observational, monocentric study. This study wants to test if among a smoking cessation intervention, behavioural counselling by video session is related to higher compliance and higher success rate than standard smoking cessation activity (face to face counselling).

This intervention was structured on Sitab guidelines (Società Italiana Tabaccologia - Italian Tobacco Society), who suggest to use long-term counseling for at least six months and preferably for 12, in order to strengthen abstinence and cover the period with the highest risk of relapse. Clinicians who follow these guidelines must provide a path greater than or equal to 4 meetings and they will have a greater degree of success if the time that will be devoted to meetings is consistent. The group that will carry out the psychological counselling in the presence will have 6 meetings (spread over 6 months) with a psychologist at the anti-smoking center of the San Raffaele Hospital and a final phone call 12 months after the first meeting to verify the maintenance of abstinence. The meetings at the anti-smoking center are aimed at monitoring the progress of the smoking cessation process, thanks also to tests (fagestrom test, motivational questionnaire, smoker's diary) and prevent any drop outs. The group that will be followed in remote mode will carry out the same number of interviews as the group described above and a 12-months call will also be made to them to check the state of abstinence. The difference between the two groups is in the way interviews were conducted.

Both face-to-face interviews and those through videocall allow smokers, in addition to learning strategies to limit the consumption of the substance, to share the path towards de-exhaustion with a professional and be supported by it.

The subdivision into the two groups will be carried out through voluntary choice of participants.

Eligibility Criteria:
Inclusion Criteria:

* Strong smokers (pack years \>= 20)
* Over or equal the age of 50
* Able to sign specific informed consent for the study

Exclusion Criteria:

* Not having plans to quit smoking
New Indications for Ultrasound in the Staging of Cervical Cancer

The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the staging of cervical cancer.

1. 3-D-ultrasound of the tumour to estimate its volume and local spread
2. Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* Cervical cancer,
* PET/CT pos. lymph nodes,
* Patients over 18 years old

Exclusion Criteria:

* Pregnancy,
* Lactating,
* Diabetic
Lung Nodule Characterization by Artificial Intelligence Techniques

Management of incidental lung nodule is difficult and mainly based on simple morphometric characteristics such as maximum size and shape. Radiomics could play a role in simplifying this management by orientating towards a benign or a malignant origin, by comparing advanced characteristics to a large database of lung nodules.

The primary purpose is to evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.

The secondary objectives are:

* to evaluate the variation in the performances of the software based on various technical aspects of the CT, such as radiation dose, reconstruction algorithm, type of scanner,...
* to compare the performances of this software to those of expert readers,
* to analyze the potential impact of this software on patient's management.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (at least 18 years old);
* With a chest CT acquired between Jan 1 2012 and Oct 1 2018 at the Strasbourg University Hospital;
* CT being available over the PACS and exhibiting at least one lung nodule;
* Patient having given its authorization for the exploitation of his medical data for this research.

Exclusion Criteria:

* Patient having expressed direct opposition to participation in this study;
* Patient under juridical protection;
* Patient under tutelage or guardianship.
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.

This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.

Eligibility Criteria:
Inclusion Criteria:

* histologically verified colorectal cancer
* clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
* age: 18-70 years
* ECOG 0-2
* adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
* no prior cancer and/or chemotherapy
* signed informed consent

Exclusion Criteria:

* patients with a history of prior malignancy
* pregnant or lactating patients
* known or suspected brain metastasis