cyrilzakka/clinical-trials huggingface dataset:
Tarp Assisted Cooling of Hyperthermic Individuals

This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness.

This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness. 12 healthy participants (6 males, 6 females) will participate. Visit 1 will be a screening visit, consisting of informed consent followed by completion of questionnaires to determine study eligibility. Participants will have their resting vital signs (heart rate, blood pressure), height, weight, and percent body fat measured. Visits 2 and 3 will be experimental trials. Participants will complete a treadmill protocol consisting of brisk walking wearing a weighted backpack (40 lb) until core temperature reaches 40.0°C. Upon completion of exercise, participants will exit the environmental chamber and be cooled in one of two ways in a randomized, counterbalanced manner: 1) tarp-assisted cooling or 2) Standard of Care. Cooling will take place for 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Aerobic exercise at least twice weekly

Exclusion Criteria:

* History of exertional heat illness
PGT-A in Screening of Embryos in the Treatment of Unexplained Recurrent Miscarriage

uRM patients selected PGT-A from 2012 to 2016 were included in this study. Their clinical outcomes were prospectively observed and analyzed to explore the factor influenced the outcomes.

This prospective observational study enrolled all women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016. If a couple underwent multiple stimulation cycles during the research period, only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A. All included stimulation cycles involved intracytoplasmic sperm injection insemination. After successfully fertilized embryos formed blastocysts on Day 5-7, trophoblasts were biopsied to determine embryonic karyotypes. The blastocysts with normal/balanced test results were cryopreserved, whereas abnormal blastocysts were discarded after notifying the patients. All normal blastocysts from a patient were thawed and transferred singly, and the outcomes of all subsequent frozen-thawed embryo transfer cycles were followed-up until January 2020.

Clinical outcomes included the blastocyst formation rate, the proportion of blastocysts with normal karyotypes, and the clinical pregnancy, live birth, and cumulative live birth rates. The factors that affected these clinical outcomes were analyzed to predict outcomes and guide treatment in women with uRM.

Eligibility Criteria:
Inclusion Criteria:

women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016.Only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A.

Exclusion Criteria:

Couples with parental chromosomal abnormalities were excluded, as were women with anatomical abnormalities of the uterus, autoimmune diseases, and endocrine abnormalities.
Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,


Eligibility Criteria:
Inclusion Criteria:

* These criteria depend on the subgroup belongs to the patient.
* Signed consent
* Membership of a social security system

Exclusion Criteria:

* Whatever the patient group or control:
* Processing immunosuppressive.
* Processing by a monoclonal antibody.
* Previous treatment with an immunosuppressant for a significant period of time (more than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures mitoxantrone).
* Carcinomatous pathology known evolving.
* People under guardianship.
* Pregnant women.
* Patients not motivated to study. Known patients with anemia (hemoglobin \<10g/100ml)
The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans

Type 2 diabetes is characterized by increased insulin resistance and impaired insulin secretion. In addition, type 2 diabetes is associated with low grade inflammation indicated by increased levels of proinflammatory cytokines such as TNF-α. TNF-α has previously been shown to impair peripheral insulin signaling in vitro and in vivo. However, it is unclear whether TNF-α may also affect endogenous glucose production (EGP) during fasting and glucose stimulated insulin secretion (GSIS) in vivo.

We hypothesized that low dose TNF-α would increase EGP and attenuate GSIS. Recombinant human TNF-α or placebo was infused in healthy, non-obese and non-diabetic young men (n=10) during a 4-hour basal period followed by an intravenous glucose tolerance test (IVGTT).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* Age 20-35

Exclusion Criteria:

* obesity (BMI\>25)
* diabetes
* chronic disease
BostonGene-Integrated Genomic Registry (BIGR)

The purpose of this project is to develop a comprehensive database of genomic, transcriptomic, molecular, and clinical characteristics of oncology patients to discover, define, and develop genomic and transcriptomic markers to improve future clinical outcomes across cancer types

Immuno- and targeted therapies have shown promising results for many types of cancer (1). However, the effectiveness of these treatments is not optimal for many patients (2). Therefore, further research is needed to discover, define, and develop genomic, transcriptomic, and integrated molecular markers that can improve clinical outcomes across cancer types (3). Unfortunately, current research is restricted by the limited availability of genomic and transcriptomic results linked to clinical outcomes (3). This study will allow for the collection of key clinical data, including longitudinal follow-up, linked with individual genetic and molecular findings in a single comprehensive registry-based databank. Analysis of these data may lead to advances across cancer subtypes through the identification of transcriptomic and genomic associations with therapies.

Clinical and pathological information, including detailed genetic information from a participant's tumor biopsy, will be obtained by the research staff for each participant enrolled in the BIGR Study. Clinical information will include relevant details about the patient's diagnosis and treatment and will be stored in a secure electronic registry database. No extra scans or procedures for this study will be collected as part of this study. Information will be collected regarding a participant's initial diagnosis, treatment, and outcome. To obtain this information, study staff will contact participants or a participant's doctor at regular time intervals for up to 15 years.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected or confirmed malignancy
2. Planned comprehensive genomic (\> 100 genes) and/or molecular analysis; or genomic and/or molecular data available from prior sequencing
3. Baseline demographics and treatment information available
4. Willingness for future contact by BIRG study personnel to provide information regarding associated cancer outcomes and treatment.
5. Signed informed consent to participate in the study.
6. Living in the United States at the time of enrollment

Exclusion Criteria:

Life expectancy \< 3 months
Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

* History of chronic migraine for at least 6 months prior to the screening visit
* Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)

Exclusion Criteria:

* Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia
* Use of headache prophylaxis medication within 4 weeks of the screening visit
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* Previous use of any botulinum toxin of any serotype for any reason
* Skin infections or acne that would interfere with the injection sites
* Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of screening.
Validation of the French Version of the Geriatric Mental State (GMS)

A major public health issues of today's aging population is the development of knowledge and expertise in geriatric medicine and psychiatry of the elderly. The depressive disorders and dementia, are among the psychiatric conditions most common in older age. They are the subject of much clinical research, in which brain imaging techniques used to establish correlations anatomo-clinical and radiological-clinical. The prerequisite for the realization of such work locally, is the validation in their French version of clinical assessment tools most commonly used internationally, ensuring reliability, acceptability and comparability of results. Among these tools, "Geriatric Mental Schedule (GMS) Package", is the reference tool for research in psychiatry of the elderly. It is a standardized and structured questionnaire that allows to establish with reliability and reproducibility on the basis of answers to questions, major psychiatric diagnoses in the elderly. It has been validated in several languages (German, Spanish, Italian, Dutch, but also Chinese, Korean ...), but is still not available in French.

Hypothesis: Validate the the French version of "Geriatric Mental Schedule (GMS) Package", to establish diagnoses of dementia and depressive disorders.

Patients 65 years or more, Nearest available to assist with the interview of informal caregivers For the subjects in the "dementia", meets the ICD-10 criteria for dementia, and CDR score at 1 to 2, with or without treatment For the subjects in the "depression", ICD-10 criteria for major depression, score on the depression scale MADRS of 18 or more, with or without treatment For control subjects, level of education based on the number of years of schooling (compulsory education until 16 years, extended school) Affiliation with a social security scheme Consent signed by the subject and the near Non-inclusion criteria Subjects with symptoms involving mixed dementia and depression such as not allowing complete ICD-10 criteria for dementia or depression.

Eligibility Criteria:
Inclusion Criteria:

* Nearest available to assist with the interview of informal caregivers For the subjects in the "dementia", meets the ICD-10 criteria for dementia, and CDR score at 1 to 2, with or without treatment For the subjects in the "depression", ICD-10 criteria for major depression, score on the depression scale MADRS of 18 or more, with or without treatment For control subjects, level of education based on the number of years of schooling (compulsory education until 16 years, extended school)

Exclusion Criteria:

* Subjects with symptoms involving mixed dementia and depression such as not allowing complete ICD-10 criteria for dementia or depression.
Evaluating a Bidirectional Priming Intervention for Goals-of-care Communication in Oncology

This pilot study will evaluate whether an intervention aimed at hospitalized patients with advanced lung and gastrointestinal cancers can help facilitate goals-of-care (GOC) communication with their oncologists after discharge.

While GOC communication is a recommended component of routine oncology care, many patients with solid cancers do not have the opportunity to talk with their oncologist about their goals and end-of-life preferences. Prior research has shown that a systematic method of prompting GOC communication with at-risk patients would address a key barrier to timely GOC communication and ensure that patients receive care that is in line with their personal preferences.

This trial will enroll 80 participants, who will be randomized 1:1 to either an intervention or a control group. Participants in the intervention group will complete a short survey regarding their goals, preferences, and disease understanding. Survey responses will be shared with each participant's outpatient oncology team. Oncologists will subsequently receive a nudge in the electronic medical record reminding them of key survey responses and encouraging them to discuss them at the patient's first clinic visit after hospital discharge.

The primary feasibility outcome is intervention completion rate and the primary clinical outcome is GOC documentation within 30 days of discharge in the intervention group compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

1. Unplanned admission to the HUP Solid Oncology service;
2. Underlying diagnosis of advanced lung or GI cancer, defined as metastatic or locally advanced disease;
3. Anticipated discharge within the next 72h; and
4. Primary oncologist is based at HUP; or
5. Family member/caregiver of a patient meeting the above 4 criteria.

Exclusion Criteria:

1. Unable to complete survey in English.
Exercises to Enhance Uterus Involution

The goal of this randomized controlled study was to compare the effect of aerobic exercise and pelvic floor muscle strengthening exercises on uterus involution. In the scope of study following questions will be answered at the end of the study. First which of the exercise type is more effective to enhance uterus involution? Secondly, does exercises induce changes in lactation rate during the study period? Thirdly, does exercises improve the experienced pain? Study will be consisted of three groups as control group, pelvic floor exercise group and aerobic exercise group. Control group will take routine gynaecological treatment. Pelvic floor muscle strengthening exercise group will attend to seven day pelvic floor strengthening exercise programme. Aerobic exercise group will attend to seven day aerobic exercise programme consisting of walking.

A total of 45 mothers who satisfies the eligibility criteria of the study will be recruited to the study. Following to the recruitment process mothers will be randomly assigned to the one of the three groups. Mothers in the control group will only take routine gynecologic treatment. Mothers in the aerobic exercise group will attend to aerobic exercises starting from the second day of the hospitalization for one week. Mothers who will be in pelvic floor strengthening exercise group after the randomization will be asked to perform six exercises with moderate difficulty that are recommended by the national association for incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Age of 19 to 35 years
* New born APGAR score is equal or higher than 8
* First pregnancy
* Giving birth in 37th to 40th weeks of the pregnancy
* Birthweight ranging from 2500 g to 4000 g

Exclusion Criteria:

* Eclampsia
* Puerperal psychosis
* Severe preeclampsia
* Multiple pregnancy story
* Uterus abnormality story
* Uterus surgery story
* Use of artificial estrogen
* Existence of systemic, mental or pregnancy related diseases
* Occurrence of complication during or after the pregnancy
* Symptoms of uterus subinvolution
Cognitive Behavioural Therapy-Informed Groups for Psychosis

This is a feasibility study of cognitive behavioural therapy-informed groups for psychiatric inpatients with positive symptoms of psychosis.

The majority of inpatients at Parkwood Institute Mental Health have symptoms of psychosis. In line with Health Quality Ontario standards for the treatment of psychosis, the investigators would like to implement and evaluate cognitive behavioural therapy for psychosis (CBTp) informed groups. The feasibility, acceptability, and preliminary efficacy of CBTp groups for inpatients will be examined. Pragmatically, the investigators propose to undergo training in CBTp, implement empirically-supported CBTp protocols developed for inpatients, track outcomes, and publish our findings. The investigators would also incorporate patient feedback to improve future iterations of the protocol. Such an undertaking would build research capacity in front line staff by encouraging engagement in CBTp group training, survey design, participant screening, data collection, analyses, and dissemination of findings.

Eligibility Criteria:
Inclusion Criteria:

* Can read/write in English
* Has positive symptoms of psychosis that are distressing to them

Exclusion Criteria:

* Inability to tolerate group participation
Pharmacogenetics Study on the Effects of Anesthetic Drugs on Circulatory Function

This study intends to study the effects of anesthetics on Circulatory Function Genomics and find the anesthetic effects in pharmacodynamics, pharmacokinetics, drug receptor or target DNA level differences, further guiding individual treatment in clinic, promoting the development of precision the medicine.The anesthesia medication during perioperative period is more and more accurate,reasonable and safe, so as to improve the satisfaction of the patients and their families in the perioperative period, to ensure the safety of patients.

This study is a non traumatic and non intervention study, and will use a large sample of clinical research, the number of subjects to be enrolled in the study group are 200 cases. The basic information of the study was included in the study before the operation. During the operation, the investigators need a collection of participants's arterial blood and monitor the hemodynamic index and anesthesia depth by bispectral index(BIS) . Further more，the investigators will follow up the participants' condition after operation.Dividing the patients into different groups according to their clinical features.The relationship between vital signs and the depth of anesthesia was analyzed and compared between different groups.Blood samples collected during the operation were detected by gene test. Comparing the results of genetic testing and clinical data analysis, then the investigators will find the differences in the expression of the gene polymorphisms of anesthetic drugs in the circulating function.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing general anesthesia
* Undergoing Cardiovascular surgery

Exclusion Criteria:

* ASA granding more than five
* Severe organ dysfunction
Early Prediction of Fluoxetine Response

The purpose of this study is to identify what degree of symptom changes during the early weeks could be used to predict eventual nonresponse at week 6 among depressive inpatients taking fluoxetine.

Patients with major depressive disorder will receive 20 mg/day of fluoxetine for six weeks. Symptom severity was assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at weeks 0, 1, 2, 3, 4 and 6. Stable response is defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment. Receiver operating characteristic curve will be used to determine the cutoff point of the percentage of HAMD-17 score reduction between stable responders and nonresponders at weeks 1, 2, 3 and 4.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of major depressive disorder
* HAM-D-17 ≧17
* written informed consent

Exclusion Criteria:

* Comorbid of substance abuse/dependence
* Comorbid with mental disorders due to general medical conditions
* Past history of treatment-resistant depression
* Severe physical problems
* pregnant women
* lactation
Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients

This is an open-label, multi-center, two-part, parallel-design study to assess the PK, safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.


Eligibility Criteria:
Inclusion Criteria:

* males and females, between 12 and 17 years of age, inclusive;
* receiving prophylaxis for or have a confirmed or suspected infection with Gram positive bacteria and receiving concurrent antibiotic treatment with Gram positive antibacterial activity
* in stable condition
* females must be premenarchal, surgically sterile, abstinent, or practicing an effective method of birth control
* males will either be surgically sterile, abstinent, or practicing an effective method of birth control

Exclusion Criteria:

* relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results
* any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this clinical study
* physician-diagnosed migraine headaches
* history of infection with hepatitis or other significant hepatic disease
* females who are pregnant or breast feeding