cyrilzakka/clinical-trials huggingface dataset:
The Effect of Intrathecal Magnesium Sulfate on Shivering

Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be used intrathecally, is effective in preventing tremor. But what is the ideal dose?

Perioperative shivering during cesarean section (CS) under neuraxial anesthesia (NA) is clinically common, but its treatment is often neglected.

When the literature is scanned, perioperative tremors are seen in 55%-60% of patients undergoing neuraxial anesthesia. However, the mechanism of the tremor has not been fully elucidated. Possible factors that can cause tremor can be listed as follows:

1. Loss of thermoregulatory vasoconstriction below the block level,
2. The displacement of body temperature from the central to the periphery due to vasodilation,
3. Increased sweating threshold and decreased peripheral vasoconstriction Perioperative shivering is a complication that needs to be treated because it causes dangerous consequences in patients with low cardiopulmonary reserve due to increased oxygen consumption and impairs patient and surgeon comfort.

Magnesium sulfate is one of the most effective adjuvant drugs with the least side-effect profile in the treatment of tremor after noxial block.

Eligibility Criteria:
Inclusion Criteria:

* Who were scheduled for elective C/S under SA,
* 18-40 years of age
* ASA physical status I-II.

Exclusion Criteria:

* Any contraindications to SA,
* preoperative body temperature \>38 C,
* allergy to any drug used in the study,
* pre-eclampsia, and eclampsia,
* neuropathy,
* respiratory distress,
* coagulopathy, and
* any possible drugs that can change body temperature,
* ASA physical status \> II.
Cross-sectional Study on a Given Day Within the Paris Saint-Joseph Hospital Group

Sleep apnea syndrome has an estimated incidence of 2 to 4% in the adult population and more so in men and with aging. It is an independent risk factor for mortality. Cardiovascular pathologies, diabetes, and stroke are known comorbidities with a high rate of association. There is no recommendation to screen these patients although the interest is assumed and sleep apnea syndrome is largely underdiagnosed. Interrogation and clinical examination guide but they are neither sensitive nor specific. The use of scores improves screening. In the general population, the Berlin score has a high false negative rate. The STOP-BANG score is sensitive but with a poor positive predictive value. Combined, these scores can be used to detect Sleep Apnea Syndrome. The interest of a management was especially shown for the very symptomatic syndromes because it is a pledge of observance of the treatment, itself necessary for the effectiveness in the prevention of the cardiovascular complications.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is\> 18 years
* Any patient hospitalized on the day of the survey in any of the services of the cardio-neurovascular division of the Paris Saint-Joseph Hospital Group, whatever the history of comorbidities, the reason for hospitalization
* Francophone patient

Exclusion Criteria:

* Patient under tutorship or curatorship
* Patient deprived of liberty
* Patient at the end of life
* Patient opposing his participation in the research protocol
The Multi-disciplinary Treatment of Functional Gut Disorders Study

Randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Functional gastrointestinal disorder as defined by Rome IV

Exclusion Criteria:

* Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD)
* Age \<18 or \>80
* Non-English speaking
* Patient's from outside of metropolitan Melbourne who cannot attend clinic visits
* Prominent eating disorder
* Chronic opioid dependence
* Medications which can explain functional gut symptoms
* Surgery of GI tract that can explain functional gut symptoms
* Major, non-GI, organ dysfunction
* Pregnancy
* Major Psychiatric disorder
The Effect of Cartoon Watching During Central Venous Catheter Dressing Changes in Children With Cancer

Many medical interventions, including dressing change of central venous catheters, can cause anxiety and pain in children with cancer. The aim of this study is to determine the effect of cartoon watching technique on anxiety and pain during central venous catheter dressing changes in children with cancer.

This was a parallel randomized controlled trial with 80 children with cancer. They were randomly assigned to one of two groups, including 40 children in the control group and 40 children in the cartoon group.

Each child's anxiety was evaluated by the child using the Children's Fear Scale before, during and after central venous catheter dressing changes, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after the procedure.

The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended.

No intervention was performed to reduce anxiety and pain for children in the control group.

Parent was with their children during the procedure in both groups.

Eligibility Criteria:
Inclusion Criteria:

* 5-12 years old
* a cancer diagnosis
* having a central venous catheter
* not having taken any analgesics in the 6 hours before the procedure
* not having any visual or auditory problems that prevent watching cartoons
* being suitable motor development and cognitive level for watching cartoons
* being a child and parent volunteering to participate in the study
* the absence of any health problems that prevent communication in the parent and the child

Exclusion Criteria:

* the reporting of pain for another reason at the time of the central venous catheter dressing changes
* being of neutropenia
* being in a terminal phase of the disease
The Role of Gastric Content Microaspirations in the Pathogenesis of Idiopathic Pulmonary Fibrosis

The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for gastric microaspirations in the pathogenesis of the disease.


Eligibility Criteria:
Inclusion Criteria:

* patients with interstitial lung disorders including IPF

Exclusion Criteria:

* patients younger than 18 years or older than 85,
* pregnant women,
* patients that present with medical conditions contra -indicated for performing bronchoscopy including sedation
Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction

This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy technique in terms of reducing elevation time and perioperative complications of perforator flaps for head and neck reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* head and neck reconstruction with perforator flap
* informed consent from the patient

Exclusion Criteria:

* coagulation problem
* refused to participate
Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.

The purpose of this study is to investigating the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSCs) and secretomes to insulin resistance in Polycystic Ovary Syndrome (PCOS) patients. This study has 4 arms namely UC-MSCs treatment, secretomes treatment, UC-MSCs and secretomes treatment, and control.

The investigator hypothesized that PCOS patients with insulin resistance given combination of UC-MSCs and secretomes can improve their clinical and laboratory insulin resistance, haid ovulatory cycle and fertility. All group will be observed every 1,3, and 6 months after injection.

Eligibility Criteria:
Inclusion Criteria:

* PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea)
* Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score \>8)
* Patients with Free Androgen Index (FAI) \>4 and ovary polycystic from USG transvaginal
* Patients with Homeostatic (HOMA) IR score ≥ 1.7

Exclusion Criteria:

* Patients who are allergic to component of WJ-MSC or Secretome.
* Patients who are not currently on hormon treatment of other resistance treatment.
* Refusing or not participating in part / all of the research process.
* Patients with positive diagnosis of hepatitis A,B,C, and HIV
Simvastatin for the Treatment of Chronic Hepatitis B

The investigators have shown robust in vitro anti-hepatitis B activity of simvastatin alone and synergistic activity with all four FDA-approved anti-hepatitis B oral drugs tested. The investigators propose phase 1 studies in 48 chronic hepatitis B human carriers who have never been treated before. Doses of drugs will remain at or below FDA-approved dosage levels for cholesterol lowering (simvastatin) or hepatitis B (tenofovir or entecavir). Arm 1 will have simvastatin monotherapy only. Arm 2 will combine simvastatin with tenofovir. Arm 3 will combine simvastatin with entecavir. For maximum safety, the 3 arms and the dose groups in each arm will be filled consecutively and not concurrently. The definition of efficacy for simvastatin alone will be a 1 log drop of hepatitis B virus in 14 days. Efficacy for combination of drugs will require a 2 log drop of hepatitis B virus in 14 days. Numerous safety tests and stop rules are noted in the protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Hepatitis B positive by HBV DNA within 180 days.
2. Ages 18-70.
3. Men and non-pregnant women eligible.
4. Veteran's eligibility or appropriate health insurance.

Exclusion Criteria:

1. Use of any anti-HBV medicine within 30 days.
2. Decompensated cirrhosis as evidenced by esophageal varices, ascites, or encephalopathy. (grade 1 varices without history of bleeding will be allowed, if patient meets Child's-Pugh functional classification grade A).
3. A positive urine test for marijuana or alcohol within 2 months of screening.(Allowed to repeat tests on different days, if positive first time in order to become eligible for study.
4. Severe cardiovascular disease (ejection fraction \<20%)\* or uncontrolled angina.
5. Severe pulmonary disease (FEV1 \< 1.0).
6. Chronic renal insufficiency (creatinine clearance \<50 ml/min.
7. HIV positive patients.
The Effect of a Novel Passive Shoulder Exoskeleton During Industrial Work

After designing a first prototype of next generation industrial exoskeleton, the system should be evaluated in laboratory conditions. In order to evaluate the passive shoulder exoskeleton, designed to assist workers, a protocol is developed in which parts of industrial work is simulated. The results of this evaluation will serve as input for the next iterative design process/cycle of the prototype.

In this study 15 subjects will be recruited. During a 3.5h lab visit, each subject will perform three identical experimental trials; one trial without exoskeleton, one trial with a commercially available exoskeleton and one with the newly developed prototype. To avoid sequence bias, the order of the trials will be randomized (counterbalanced). The protocol consists of 6 tasks, always performed in the same sequence; lifting 5 kg 5 times from hip height to overhead height, completing a wiring task overhead (90 sec), 6 minutes walking, 6 min lifting from hip to overhead height (10 kg), 6 min lifting from ground to hip level (10 kg) and drilling for 30 sec with a force of 60N (±20 N). Before each task, 5 min of rest will be provided, and the subject will receive 10 min of rest in between different experimental trials. Electrocardiographic data, chest expansion and skin temperature will be monitored through a belt (Equivital, AD Instruments). An ergospirometric device (K5, Cosmed) will be used to gather gas exchange data, and (non-invasive) EMG electrodes will be applied to collect muscle activity data during the trials (Cometa). IMUs will be applied to the subjects' extremities to analyse the movement pattern (Technaid). Furthermore, questionnaires will be filled out to assess the subjective experience (Rating of Perceived Exertion, Sustained Usability Scale, Local Discomfort Scale).


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals (based on ParQ questionnaire)

Exclusion Criteria:

* work related disorders
* shoulder injuries in the past
* back injuries in the past
Culture System for Isolating Circulating Tumor cells_2

This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating tumor cells from the blood sample. The coating of the system has the characteristic that to make the WBCs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. The supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lung cancer are between the ages of 20 and 70
* Willing to sign the consent form under the informed consent

Exclusion Criteria:

* Vulnerable Subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.
Acupuncture and Mindfulness Based Stress Reduction for Wellness

AMWELL is a randomized, waitlist-controlled, pilot study to evaluate the comparative efficacy of Mindfulness Based Stress Reduction (MBSR) and Acupuncture (AT) to Wait-List Control (WL) in adult female survivors of childhood sexual abuse (CSA) experiencing symptoms of psychological distress.

Female CSA survivors at least 21 years old were recruited from newspaper ads, radio programs, study websites and various public announcements in the Baltimore, Md and surrounding area between September, 2008 to October, 2009.

Eligibility Criteria:
Inclusion Criteria:

* Female survivors of childhood sexual assault reported in a clinical interview (e.g., age at which the abuse began and continued, frequency and duration, and the perpetrator)
* At least 21 years old
* Ability to read and write in English
* Under the care of a licensed psychotherapist or physician for study duration
* Clinical approval for acupuncture or MBSD
* Ability to attend 80% of the sessions
* Willingness to practice skills 20-30 minutes per day, six days a week
* If taking psychotropic medication, on a stable dose for 30 days prior to baseline
* A score of 0.5 or greater on the Brief Symptom Inventory (BSI)

Exclusion Criteria:

* Any major illness or psychiatric disorder
* Symptom severity as evidenced by a CGI-S score of 6 or 7
* Current suicidal ideation
* Active alcoholism or drug dependency
* Current enrollment in another clinical trial
* Major surgery scheduled
* Plans to move from the area during the 12-week study period
* Current pregnancy, plans to become pregnant, or no means of birth control
Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.


Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of MDD
* Depressive symptoms for at least 30 days before the screening visit.

Exclusion Criteria:

* Treatment with DVS SR at any time in the past.
* Known hypersensitivity to venlafaxine
* Significant risk of suicide based on clinical judgment
The Use of Novel Diagnostic Tools to Increase Detection of Early Fibrosis in Cystic Fibrosis Related Liver Disease to Improve Clinical Management

Cystic Fibrosis (CF) is a genetic condition which affects 1 in 2500 newborn infants and is the commonest genetic condition in the UK. 1 in 25 of the white population carry the mutation. The genetic defect prevents the movement of fluids from cells, leading to thickened secretions and injury. With improvements in treatments from the commonest organ affected, the lungs, patients born with CF now can expect to live into their 40s with more than 60% living past 16.

Though better, more can be done. As treatments from lung complications have improved, the management of liver disease (second commonest organ involved) remains unchanged for a considerable time. Treatment options are limited with liver transplant the only curative option. Though potentially life-saving, it has risks and an organ shortage means alternative treatment options are desperately needed.

Identifying those with or at risk of Cystic Fibrosis related liver disease is difficult due to inadequate diagnostic tools. Routine blood tests are unreliable; therefore specific blood tests to identify scarring of the liver (biomarkers) are urgently needed. Ultrasound scan, the recommended diagnostic investigation, is only accurate in identifying the late stages of liver disease. For new therapies to be most effective we need to be able to identify patients at a much earlier stage.

This study will use multi-modality testing, including imaging techniques such as FibroScan, MRI scan and blood tests (biomarkers), to diagnose those with liver scarring and use this to better categorise disease.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female \> 18 years of age
2. Females will be non-pregnant and non-lactating\* (for MRI scan only)
3. 20 patients with confirmed diagnosis of CF, 20 with CFLD and 20 healthy volunteers

   * Women of childbearing potential (i.e. not surgically sterilised or \<1 year post menopause) will be required to:

1. Confirm they are not currently breastfeeding 2. Undergo a serum pregnancy test (serum β-HCG)

Exclusion Criteria:

1. Contraindication to magnetic resonance imaging scanning (including claustrophobia) or gadolinium-based contrast agent
2. eGFR \< 50 mL/min/1.73m2
3. Pregnant or breast-feeding women.
4. Any other condition, which in the opinion of the research team may put participants at risk during the study.
Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients

This is a pilot study. The purpose of this study is to determine whether adding 4 months of behavioral therapy to primary care physician medication treatment(relative to medication treatment alone) improves outcomes for persistently depressed primary care patients.


Eligibility Criteria:
Inclusion Criteria:

* Current MDD or MDD within the past year or current dysthymia
* PHQ-9 \> 10
* have been prescribed an antidepressant medication (by their PCP) at least 8 weeks before pre-treatment timepoint
* are able to speak, read, and understand English sufficiently well to complete study procedures
* are between the ages of 18 and 70

Exclusion Criteria:

* presence of significant suicidal ideation or risk
* history of bipolar disorder, schizophrenia, psychotic symptoms, or severe alcohol or drug problems within the past year;
* history of antisocial personality disorder or borderline personality disorder;
* currently in psychotherapy or have received counseling more frequently than once per month in the past year.
A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors

This is a multi-center, open label, phase Ib/II clinical study of AK109 and AK104 to evaluate the safety, tolerability, effectiveness, pharmacokinetic characteristics in advanced solid tumors .


Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent.
2. Age ≥ 18 years and ≤ 75 years.
3. ECOG Performance Status of 0 or 1.
4. Estimated life expectancy of ≥3 months.
5. Histologically or cytologically documented, locally advanced or metastatic solid tumours (NSCLC, mCRC, HCC, GEJ, etc. ), for which standard therapy does not exist or has proven ineffective or intolerable.
6. At least one radiographically measurable lesion per RECIST 1.1.
7. Tumor biopsy (during advanced stage) available.
8. Adequate organ function.
9. Female participants of childbearing potential and male partners with female partners of childbearing potential must agree to use effective barrier methods of contraception during the study and for 120 days after last dose of study drug.

Exclusion Criteria:

1. Other documented active malignancies other than for this trial within 3 years.
2. Participation in other clincial trials simultaneously.
3. Use of systemic anti-tumor treatments with 4 weeks, non-specific immunomodulating agents within 2 weeks.
4. Prior exposure to other T cell coregulatory proteins except for PD-1/PD-L1 inhibitors (apart from cohort B, i.e. treatment naive HCC patients).
5. Current use corticosteroids/immunosuppressive agents, permanently discontinuation of study drug, or having any unresolved irAEs (≥grade 2) from prior PD-1/PD-L1 inhibitors treatment.
6. Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.
7. Uncontrolled pleural/pericardial or peritoneal effusion.
8. History of hemorrhagic event need blood transfusion, invasive approaches to intervene, or hospitalization within 3 months, or having high risks of bleeding.
9. Any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 months.
10. Uncontrolled gastrointestinal diseases.
11. Use of NSAIDs and anticoagulant agents within 7 days.
12. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks.
13. Severe or uncontrolled hypertension and cardiovascular/cerebrovascular diseases.
14. Uncontrolled comorbidities need corticosteroids using.
15. Active or prior autoimmune disease or history of immunodeficiency.
16. History of interstitial lung disease.
17. Known history of active tuberculosis (TB).
18. Evidence of active infections including hepatitis B and C.
19. Use of anti-infectious agents within 2 weeks.
20. History of human immunodeficiency virus (HIV) infections.
21. Active syphilis infections.
22. Any unresolved toxicities (≥grade 2) from previous anti-cancer therapies.
23. Mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements.