cyrilzakka/clinical-trials huggingface dataset:
A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic.


Eligibility Criteria:
Inclusion Criteria:

Part I

* Age ≥45 years
* Scheduled visit with a nongynecologic surgeon
* Female or assigned female at birth

Part II

* Age ≥45 years
* At least one in situ fallopian tube
* No desire or plan to have children in the future
* Average risk of developing ovarian cancer

  ° Note: Average risk patients are defined as patients with no known genetic risk factor for developing ovarian cancer. Patients who, after obtaining family history, are suspected to have a hereditary ovarian cancer syndrome but have not yet been tested, will be referred for genetic evaluation.
* Planned nongynecologic, intraabdominal, or pelvic surgery
* Deemed to be a suitable candidate by gynecologic surgeon and primary nongynecologic surgeon (for example, on the basis of surgical history and current malignancy status)
* Approved and signed informed consent

Exclusion Criteria:

Part I

* Not fluent in English

  ° If there is a non-english speaking participant who is a strong candidate and meets all other criteria for Part 2, they are able to go directly onto Part 2 without completing Part 1. (Please see additional details in section 4.1 and 7.0.)
* Known inherited ovarian cancer susceptibility

Part II

* Personal history of a gynecologic malignancy
* Carrier of a hereditary breast or ovarian cancer variant (e.g., BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2)
* Suspicious ovarian, fallopian tube, or uterine lesion on preoperative imaging
* Previous bilateral salpingectomy or bilateral salpingo-oophorectomy
* Current pregnancy
* Emergent procedure or emergency procedure that has to be completed within 24 hours where clinical consent occurs in the inpatient setting or where the patient's immediate well-being is in danger or condition may be life threatening
* Primary surgeon anticipates that OS will add significant time (\>30-40min) to the planned procedure.
* Inability to access the pelvis (ex., patient prone/lateral position) during the planned procedure.
* Known history of pelvic fibrosis or significant adhesions.
* Procedures with palliative intent only
Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer

This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time between randomization and the discontinuation of the second treatment in the sequence) will be similar for both arms of the study. The quality of life during this period, however, could be better in the patient group receiving the most effective first agent in the sequence. If this proves to be true, the conventional wisdom that endocrine therapy should be continued until no further endocrine options remain, must be abandoned.

This is a randomized phase II/II study. Patients are randomized for the sequence capecitabine-hormonal therapy versus hormonal therapy- capecitabine. At progression the patient should receive the other protocol treatment (e.g. if the patient was randomized to capecitabine, at progression the treatment should be switched to hormonal treatment).

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.
3. Positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). Progesterone and HER-2 neu receptor have to be known.
4. - Progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. Simultaneous use of LH-RH analogs is allowed. OR - Recurrence of disease (M1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor).
5. No prior chemotherapy for metastatic disease
6. Willing and able to participate in Quality of Life investigation -

Exclusion Criteria:

1. Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
2. Pregnancy or breast feeding women.
3. Contra-indications to the use of capecitabine
4. Known CNS metastases
Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance

The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean section and in women under general anesthesia improves lung compliance and gas exchange. The investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8 cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment maneuver. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O

The investigators used recruitment maneuver during cesarean section and in women under general anesthesia. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O after the recruitment maneuver. The investigators used 2 groups of patients. In the first group the investigators used pressure control ventilation for the recruitment maneuver. After the ventilator was switched to pressure control mode the investigators increased the inspiratory time to 50% and the inspiratory pressure above Positive End Expiratory Pressure (Ppeak) to 20 cmH2O. Then the investigators progressively increased Positive End Expiratory Pressure (PEEP) to have a peak inspiratory pressure (Ppeak) to 45 cm H2O. The whole recruitment maneuver lasts 2 minutes. After the recruitment maneuver the investigators used volume control ventilation again (with the baseline settings)and PEEP step wised decreased to 8 cmH20but. PEEP (8cmH2O) was left until the end of the operation. In the second group the investigators did not used lung recruitment maneuver at all. In both groups lung compliance was measured (dynamic and static)as dv/dp (ml/cmH2O). Measures were assessed 1 minute after delivery (but before recruitment), 3 minutes after recruitment (first group) at 10 and at 20 minutes after recruitment. The investigators also measured Ppeak (cmH2O) and Pplateau (cmH2O)inspiratory pressures , blood pressure (mmHG), beats per minute, oxygen saturation, end-tidal CO2 according to the above time frame, blood Gases before and 3 minutes after recruitment etc.

Eligibility Criteria:
Inclusion Criteria:

* general anesthesia,
* hemodynamically stable

Exclusion Criteria:

* intracranial hypertension,
* pulmonary hypertension,
* low blood pressure (MBP\<80 mmHg),
* Heart rate \> 100 beats/min,
* patient refusal
SERUR: COVID-19 Serological Survey of Staff From the University Reims-Champagne Ardennes

This study was designed to determine, in a screening situation within the framework of university preventive medicine, the prevalence of positive anti-SARS-Cov 2 serology among the staff of the University of Reims Champagne-Ardenne. The serological tests chosen will allow systematic detection of anti-SARS-CoV-2 IgM and anti-SARS-Cov-2 IgG to assess the moment of potential contamination prior to resumption of occupational activity.

Objective:

This study was designed to determine, in a screening situation within the framework of university preventive medicine, the prevalence of positive anti-SARS-Cov 2 serology among the staff of the University of Reims Champagne-Ardenne. The serological tests chosen will allow systematic detection of anti-SARS-CoV-2 IgM and anti-SARS-Cov-2 IgG to assess the moment of potential contamination prior to resumption of occupational activity.

Type of study:

This is a prevalence study, a single-center cross-sectional study published on the human person.

Population:

Inclusion criteria: On a voluntary basis, the staff of the University of Reims Champagne Ardenne will be offered a serological blood test (1 dry tube of 7ml). The use of the collected data for research purposes will be explained to each requester, with signature of an informed consent. Only people over 18 will be included.

Non-inclusion criteria: Staff of the University of Reims Champagne Ardenne who have not requested to be tested. Duration of participation of subjects: 1/2 day time

Judgment criterion (s):

Main endpoint (in connection with the main objective): Prevalence of positive SARS-CoV-2 serology at the University of Reims Champagne-Ardenne.

Clinical investigation plan:

* Phase 1: Communication strategy An email will be sent to all the staff of the University of Reims Champagne Ardenne to offer them anti-SARS-Cov-2 serological tests, as part of a health research protocol. Before sampling, a questionnaire will be completed by the applicant.
* Phase 2: Analysis of the samples
* Phase 3: Transmission of results to Pr Frédéric Deschamps, head of SUMMPS at the University of Reims Champagne Ardenne

Eligibility Criteria:
Inclusion Criteria:

* Major volunteers from the Staff of the University of Reims Champagne-Ardenne (\>18 years old)

Exclusion Criteria (Non Inclusion):

* persons who do not desire to participate
Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study

The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents.

In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder.

Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan.

This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.

If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.

Prior studies have shown that "computer assisted cognitive remediation"--meaning using computer "games" to build up a skill that has been shown to be impaired in a specific disorder--can result in improvement in psychiatric illnesses--including schizophrenia.

This will be the first National Institute of Mental Health (NIMH)-funded study to use this "retrain your brain" approach in children and adolescents with bipolar disorder.

During this study, we are seeking 40 children and adolescents with bipolar disorder to:

* come to our lab at Bradley Hospital in East Providence R.I. twice per week (each lasting 1 hour) to "play" a special computer game for a total of 8 weeks
* to have a special MRI before and after this 8-week trial to see if our "game" improves brain activity
* it does NOT matter if your child is already on medications--they can continue during this study
* all children/adolescents with bipolar disorder are welcome--as long as they do NOT have implanted metal (no braces, no cochlear implants, etc) because of magnetic resonance imaging (MRI) safety.

This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.

If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.

Eligibility Criteria:
Inclusion Criteria:

* 7-17 years old
* bipolar disorder type I preferred (at least 1 week of mania)

Exclusion Criteria:

* no implanted metal (no braces, no cochlear implants)
* can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder
* no active drug/alcohol abuse/dependence
Using Ultrasound and Acupuncture to Explore the De-qi Location and Reaction of Specific Acupoints

According to ancient literature, when de qi occurs in the process of acupuncture, the patient may experience sensations such as soreness, numbness, heaviness, swelling. Meanwhile, the acupuncturist may experience the sensation of "a fish taking a bite from the bait on a hook". However, for a beginner at acupuncture, before they have learned to trigger the de qi sensation, it is hard for them to learn according to the ambiguous definition of "a fish taking a bite from the bait on a hook" and thus hard to know whether they have reached the correct location and stimulated de-qi. In this study, through multiple experienced acupuncturists acupuncture multiple test subjects, the investigators will locate the location and the reaction of de qi on the acupoint Quchi (LI11) with ultrasound observation and recording. Through the ultrasound teaching and guidance, the investigators will test whether it is possible to reversely use ultrasound imaging to guide less experienced acupuncturists to the de qi location and elicit de qi response on multiple test subjects. Therefore, the investigators propose this study to test the following hypothesis:"There is a specific anatomical site where de qi occurs at LI11, and it is possible to use ultrasound imaging to guide learners to reach that location and trigger de-qi and that it is applicable to other acupoints". To explore the above hypothesis, the investigators will target the following specific aims. Aim 1: Use ultrasound record and indicate the precise anatomical location and reaction when de qi occurs on acupoint LI11. Aim 2: Simultaneously record the physicians' needling sensations, the participants' needling sensations, twitch response of the participant under ultrasound images. Aim 3: Prove the feasibility of using ultrasound to guide inexperienced physicians to reach the correct location and elicit de qi sensation on the participants. Aim 4: Discuss the relationship between de qi and pulse diagnosis. Aim 5: Apply the above procedures to other acupuncture points such as LU5(Chize), PC3 (Quze),...etc.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 20 years and healthy subjects

Exclusion Criteria:

* pregnancy
* patients with chronic diseases such as hypertension, diabetes mellitus, chronic hepatitis, chronic kidney disease
An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis

The purpose of this research study is to determine whether a low dose of ATRA will improve laboratory tests of liver and bile duct inflammation in patients with PSC. The investigators will also look for changes to other blood tests which are related to inflammation, scarring, and the immune system.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 18-80
* Diagnosis of large-duct PSC based on ERCP or MRCP, or liver biopsy findings without alternative explanation for findings, for at least 6 months.
* Serum ALP levels persistently more than 1.5 x upper limit of normal over the past 6 months.
* Ursodeoxycholic acid therapy must be discontinued for at least 3 months.
* At least 2 forms of barrier protection for males and females of child-bearing age.

Exclusion Criteria:

* Small duct PSC, overlap with autoimmune hepatitis, IgG4 disease or secondary sclerosing cholangitis.
* Any malignancy, presently or within the past 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or in situ prostate cancer.
* Viral hepatitis including hepatitis A, B, C, D, E.
* Decompensated cirrhosis, or planned liver transplantation.
* Recent diagnostic or therapeutic biliary manipulation (endoscopic, radiologic) within the past 3 months.
* Ascending Cholangitis requiring antibiotics within the past 3 months.
* Uncontrolled IBD, or IBD requiring the use of steroids.
* Acute or Chronic Kidney Disease with serum creatinine \> 2 mg/dL.
* Allergy to ATRA or vitamin A compounds.
Maternal Attachment and Depression Anxiety Score Evaluation in COVID-19 Positive Pregnant Women

Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in patients with covid-positive pregnancies in the 3rd month after birth.

Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale are evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.

Eligibility Criteria:
Inclusion Criteria:

* covid -19 positive and negative pregnant women
* have no psychiatric illness
* not using antidepressants or antipsychotic drugs

Exclusion Criteria:

* women with psychiatric illness
* using antidepressants or antipsychotic drugs
* not pregnant
* adolescent pregnancy
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1018 and Coadministration of BR1018A and BR1018B in Healthy Adult Volunteers

The purpose of this clinical study is to evaluate the pharmacokinetics and the safety after administration of BR1018 and coadministration of BR1018A and BR1018B in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who have body mass index (BMI) of more than 18.0kg/m2 and less than 30.0kg/m2 at screening visit.

  * For men, Those who weigh 50 kg or more
  * For women, Those who weigh 45 kg or more
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagree to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (However, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first administration date. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours before the first administration date
* In the case of a female subject, those suspected pregnancy or pregnant woman or lactating woman.
Students' Understanding and Beliefs About Pain Before and After a One-day Pain Science Education Conference: an Intervention

The beliefs held by students lead to behaviours in response to their pain which can be both helpful or a hindrance to how they manage their pain. The one-day education event aims to educate the cohort on the contemporary scientific understanding of persistent pain using a mixture of methods. It is hoped this event will result in an improvement in the alignment of beliefs and behaviours to contemporary understanding of persistent pain.

The principal aim is to evaluate the pre-post knowledge and beliefs about pain following a one-day pain education event in year 12 students, aged 16 or above.

The students will be asked to complete questionnaires three times relating to their understanding and beliefs relating and intended behaviour in the presence of pain. Once at the start of the conference and once at the end, then finally after 3 months. The questionnaire will gather demographic information (age, gender, ethnicity and any history of persistent pain). There will also be a series of multiple-choice questions relating to knowledge and beliefs about persistent pain. The three time points of questionnaire completion will see the students complete the same questionnaire except they will not have to repeat demographic questions. The questionnaire should take 5-10 minutes to complete each time. The questionnaires will be provided online and links will be provided to participants.

This is a non-randomised controlled trial and a second school selected as it is part of the same group of schools and equally matched according to the English Indices of Deprivation 2019. This school will complete the survey at the same time points.

Eligibility Criteria:
Inclusion Criteria:

* Students at two specified schools in North Yorkshire who had been offered the pain study day in year 12 or are in the intervention or control school in year 12 or 13
* Aged above 16.
* Providing consent to participate.

Exclusion Criteria:

* Students not providing consent.
A Study to Assess Variation in Potential Biomarkers in Friedreich Ataxia

To test the variability of specific ribonucleic acid (RNA) and proteins as well as frataxin levels in samples of blood and buccal cells taken directly from patients with Friedreich's ataxia (FRDA) in order to confirm potential new biomarkers of disease in patients with FRDA.

Primary Objective:

The primary objective of this study is to identify whether frataxin levels and specific RNAs and proteins in blood and buccal cells differ between patients with FRDA and controls.

Secondary Objective:

The secondary objectives of this study are:

* To understand the variability of frataxin and specific RNAs and proteins identified in buccal cells.
* To correlate levels of frataxin and specific RNAs and proteins with features of FRDA.
* To correlate levels of frataxin and specific RNAs and proteins with triglycerides, high density lipoprotein (HDL), low density lipoprotein (LDL) levels, and other lipids.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients with FRDA confirmed by genetic testing (FRDA subjects only).
2. Children and adults between the ages of 12 and 65 (inclusive); age for controls will be +/- 2 years relative to FRDA subjects.
3. Subject (and/or parent/legal guardian) has voluntarily signed consent form.
4. Willingness and ability to comply with all study procedures.
5. Functional Disability Stage (FDS) of 3, 4, or 5 (FRDA subjects only).

Exclusion Criteria:

1. Treatment with an investigational product within 30 days of study.
2. Use of gamma interferon or receiving any dose of gamma interferon within 90 days of the specimen collection day.
3. Use of any statin medications within 90 days of the specimen collection day.
4. Use of any lipid-lowering agents within 6 weeks of the specimen collection day.
5. Use of daily biotin supplementation that exceeds 30 mcg/day, either as part of a multivitamin or as a standalone supplement, within 7 days of the study visit.
6. Pregnant women.