cyrilzakka/clinical-trials huggingface dataset:
Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients with Parkinson' Disease

Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 10 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. The grouping situation remains blinded for the patients, TMS analysts, and video analysts.)


Eligibility Criteria:
Inclusion Criteria:

* Meets the clinical probable Parkinson's disease diagnostic criteria proposed by MDS-UPDRS;
* Disease duration of 4 years or less;
* Unmedicated or has been off medication for more than 12 hours, with H\&Y stage ≤ 2.

Exclusion Criteria:

* History of stroke or seizures, dementia; previous surgical interventions for Parkinson's disease; contraindications for TMS (such as cardiac pacemakers, transcranial implants, and metal implants); severe mental disorders such as depression or psychosis; inability to understand the study procedures; use of antipsychotic medications; pregnancy.
Improved Factor VIII Inhibitor Evaluation

Commercial one and two-stage factor VIII assays may not detect some clinically significant inhibitor antibodies. The purpose of the proposed study is to standardize and validate a platelet-based factor VIII activity assay with greater sensitivity to clinically important inhibitory antibodies. Investigators will evaluate the platelet-dependent inhibitory activity vs. conventional inhibitory activity in stored patient plasmas and correlate to bleeding histories

Factor VIII activity assays are used to diagnose hemophilia A, to monitor treatment of these patients, to determine when inhibitory antibodies against factor VIII have developed, and to evaluate the activity of engineered pharmaceutical factor VIII products. Factor VIII activity has been measured with one and two-stage assays for more than fifty years. However, all existing assays have major shortcomings that are recognized by the FDA, the International Society for Thrombosis and Haemostasis, and pharmaceutical companies. The major deficiencies that have been identified are: 1) Factor VIII activity levels do not predict the risk of bleeding in patients with inhibitory antibodies. The degree of inhibition in these assays is less than required to explain patient bleeding. 2) The assays are only accurate over a range of 1 - 100% of normal factor VIII activity, while values of 0.1 - 1% are also clinically important. 3) The different approved assays give discrepant values for recombinant pharmaceutical factor VIII products, with a range of 2-fold difference between assays. This can lead to clinically important differences in dosing of factor VIII products from one region to another with corresponding risk of thrombosis or bleeding.

The preliminary data identify an additional deficiency of commercial assays that has not been anticipated. Commercial one and two-stage assays may not detect some clinically significant inhibitor antibodies. Thus, the purpose of the proposed studies is to standardize and validate a platelet-based factor VIII activity assay with greater sensitivity to clinically important inhibitory antibodies.

Eligibility Criteria:
Inclusion Criteria:

* hemophilia A
* presence of inhibitory antibodies

Exclusion Criteria:

* none
momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology

The purpose of this study is to find out if information and support provided with a mobile-delivered (via iPad) momHealth Teen Pregnancy Program can promote healthy choices and behaviors during and after pregnancy.

This is a RCT to pilot test an innovative multiple health behavior intervention to influence three areas of health for pregnant and parenting adolescents: breastfeeding, healthy eating/active living, and depression prevention. Intervention and control groups will be compared in the main outcomes of the study (see 4.2.c. and 4.3). Beginning in the last eight weeks of pregnancy and extending to one month after giving birth, we use mobile health technology (e.g., iPad minis) to deliver multi-media educational modules, text-messaging, virtual home visits with professionals using secure televideo, and real-time peer group support over televideo. At birth, five weeks, and three months after giving birth, effectiveness of the program outcomes will be assessed and compared to a usual care control group and include breastfeeding/infant-feeding practices; healthy eating and physical activity; and depressive symptoms. This is the first known study to address these multiple behaviors simultaneously with pregnant and parenting adolescent women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females
* English-speaking
* Giving birth to first child
* Intending to keep the newborn
* Access to a telephone
* 27-31 weeks gestation
* Low-risk pregnancy

Exclusion Criteria:

* Multiple gestation pregnancy
* High-risk pregnancy
* Women with active untreated mental health conditions such as affective disorder, substance use disorder, anxiety disorder (excluding simple phobia), or psychosis
Idiopathic Pulmonary Fibrosis (IPF) and the 3 Minutes Sit-to-stand Test

This study is designed to evaluate the reproductibility and the performance of the 3 minutes sit-to-stand test in patients with idiopathic pulmonary fibrosis.

To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis in 2 centers (Grenoble university hospital and Lyon university hospital).

Patients had to achieve an effort test on a cycle ergometer. 2 visits are planned in the hospital. During each visit, patients will perform a 3 minutes sit-to-stand test, a 1 minute sit-to-stand test and a 6 minutes walk test. During the second visit, patients will also perform a 3 minutes sit-to-stand test with measurement of oxygen uptake.

The investigators will then analyse the results by comparing numbers of cycle, functional response and symptoms during the 3 minutes sit-to-stand test of the 2 visits. The investigators will also compare the functional response obtained during the 3 minutes sit-to-stand test, the 1 minute sit-to-stand test and the 6 minutes walk test.

Finally, the investigators will compare the maximal values of oxygen uptake, respiration rate and expired volume obtained during the 3 minutes sit-to-stand test to the effort test on cycle ergometer.


Eligibility Criteria:
Inclusion Criteria:

* man or woman aged less than 85 years
* patients with Idiopathic Pulmonary Fibrosis without any acute exacerbation during 4 months before the inclusion
* Non-opposition to participation in research
* Patient with 6 minutes walk test \> 200 meters (with or without oxygen therapy)

Exclusion Criteria:

* Patient with reduced locomotor activity, or joint pain that compromises the performance of the tests
* Patient with 6 minutes walk test \< 200 meters
* Patient with an other etiology of pulmonary fibrosis
* Other significant pulmonary diseases
* Patient with unstable cardiac disease
* Patient who may be, according to the investigator's assessment, not cooperating or respecting the obligations inherent in participating to the study.
* Opposition to participation in research
Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia

This study investigated the efficacy of adipose derived stem cell conditioned media (ADSC-CM) combined with minoxidil for hair regeneration therapy in male AGA.

This study was a double-blind, randomized clinical trial (RCT). Two concentrations of ADSC-CM were utilized: concentrated and non-concentrated ADSC-CM. The scalp was divided vertically in half; one side was injected with 2 ml of ADSC-CM, while the control side received 2 ml of NaCl 0,9%. After the injection, patients applied topical 5% minoxidil twice daily. Clinical improvements were assessed using photographic evaluation and trichoscan every two weeks.

Eligibility Criteria:
Inclusion Criteria:

* males aged 25-58 years old
* Hamilton-Norwood criteria grades II to VI
* cessation of anti-androgens and minoxidil treatment for at least one month

Exclusion Criteria:

* patients with hair loss other than AGA, such as alopecia areata, chemotherapy-induced alopecia, autoimmune-induced alopecia, and scalp malignancies;
* patients receiving 5-alpha reductase inhibitor therapy;
* patients who had received growth factor treatment (platelet-rich plasma or microneedling) for at least six months prior to the study; and
* history of hypertrophic scars or blood clotting disorders.
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant)
* Have body mass index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m² to \<30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular diseases).
* Must have initiated treatment with ixekizumab for approximately 3 months (± 1 month) prior to decision to add tirzepatide.
* Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline/screening).

Exclusion Criteria:

* Have currently received ixekizumab for more than 4 months or less than 2 months.
* Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide.
* Are currently enrolled in any other clinical study.

Other exclusions

* Have a known hypersensitivity to tirzepatide or to any of its component.
* Have a personal or family history of medullary thyroid cancer.
* Have multiple endocrine neoplasia type 2.
* Have type I diabetes mellitus.
* Have a history of chronic or acute pancreatitis at any time before screening (Visit 1).
* Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.
* Have a history of ketoacidosis or hyperosmolar state/coma.
* Have a history of severe hypoglycemia and hypoglycemia unawareness within the 6 months before screening.
* Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.
Comparison of Demographic Data Mentioned by the Patients or Measured by a Physician

OSA (Obstructive Sleep Apnea) represents a major risk of postoperative complications. Predictive scores have been developed as the STOP-Bang score and the DES-OSA score. These scores take into account morphological parameters such as weight, height, and neck circumference. These data can be contained from the patients (self-reported) or by the measurements performed by a physician. The aim of this study is to compare the accuracy of both measurements (self-reported by the patient or measured by the physicians).


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for elective surgery on a one-day hospital

Exclusion Criteria:

* Patient refusal
A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis

The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Those who are ≥18 and ≤70 years of age at the time of signing the written informed consent form
* Those who have involved BSA (the percentage (%) of body surface area involved with lesion) ≥10%, PASI (Psoriasis Area and Severity Index) ≥12 and sPGA (static Physician's global assessment) ≥ 3 at screening and at baseline.

Exclusion Criteria:

* Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis
* Those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug.
King Vision® and GlideScope® in Difficult Airways

There are several advantages of video laryngoscopy; especially their ability to provide superior glottis visualization, as compared to traditional laryngoscopy.1-3 The purpose of this three arm study was to compare the safety and efficacy of the King Vision® Video Intubation Systems (AMBU-King Systems, Denmark) to the Cobalt GlideScope® (Verathon Medical Inc., USA) in patients with anticipated difficult airways.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Mallampati III-IV
* Neck circumference \> 43cm
* Reduced mouth opening (\< 4cm) or 3 Finger breath's (patient's own)
* Thyromental distance \< 6cm

Exclusion Criteria:

* Mallampati I-II
* Neck circumference \< 43cm
* Documented 'easy' intubation
* Previous history of failed intubation and failed bag-mask ventilation
* Under 18 years of age
* ASA IV
* Known unstable cervical spine injury
* Presentation for an emergency surgical procedure
Assessment of Surgically Removed Abdominal Wall Endometriomas

A retrospective review of all patients who underwent surgery for an anterior abdominal wall mass which confirmed by pathology examination as an endometrioma will be completely performed. The clinical data will be recorded and pathology report diagnosis will be correlated with the clinical data to assess the possible causes of endometrioma in the women treated in our tertiary hospital and the efficacy of the surgical excision.

Our hospital is a tertiary center for performing Cesarean sections, external endometriosis (Endometrioma) is a challenging complication for this operation, many treatment choices are available and the most common is the surgical excision, however recurrence could be seen after the surgical operation. We assess all patients who underwent surgical excision for abdominal wall endometriomas in our hospital by retrieving the medical files and pathology reports to study the possible age group,causes and duration of endometriomas. Also the rate of enodmetriomas among the previously experienced females with cesarean section operations. Pathological diagnosis tools will be also assessed.

Ethical approval was obtained from the local committee. Results will be statistically assessed using SPSS programm.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Surgically removed abdominal wall endometrioma

Exclusion Criteria:

* Male (very very rare to occur)
* medically treated enodmetrioma
* Outside treated patients
Effect of Sitagliptin in Impaired Glucose Tolerance

The purpose of this study is to examine the safety and efficacy of sitagliptin 100 mg every day (q.d.) in improving hyperglycemia and endothelial dysfunction in subjects with impaired glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese subjects aged 40-65 years with fasting plasma glucose \< 100 mg/dL and OGTT 2-hour glucose 140-199 mg/dL.
2. Subjects are judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests.
3. Subject has an understanding of the study procedures, alternative treatments available and risk involved with the study, and voluntarily agrees to participate by giving written informed consent.
4. Non-sterilized premenopausal female agrees to receive pregnancy test to confirm the non-pregnancy status and use adequate contraceptive methods to prevent pregnancy during the study period. Patient status should be confirmed by pregnancy test before enrollment.

Exclusion Criteria:

1. Evidence of diabetes (FPG\> 125 mg/dL, or OGTT 2-hour glucose\>=200 mg/dL, or current use of an anti-diabetic agents, except for history of gestational diabetes).
2. History of intolerance or hypersensitivity or contraindication as mentioned in the approved package insert (appendix).
3. Patient has any of the following disorders within the past 6 months: acute coronary syndrome (e.g., MI or unstable angina), coronary artery intervention (e.g., CABG or PTCA), stroke or transient ischemic neurological disorder.
4. Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
5. Patient has a BMI \> 40 kg/m2.
6. Patient is on or likely to require more than 14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. Note: inhaled, nasal, and topical corticosteroids are permitted.
7. Patient is on or likely to require treatment with immunosuppressive agents (e.g., cyclosporine, methotrexate).
8. Advanced renal insufficiency (estimated creatinine clearance \< 50 ml/min).
9. Severe hepatic insufficiency (Child-Pugh score \> 9, see Appendix).
Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision. The investigators hypothesize that in these procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient hemodynamics intra and postoperatively.

Neurosurgical operations are characterized by major fluid shift, frequent use of diuretics, and prolonged operative time. The role of fluid therapy in these patients is very critical, hypovolemia might lead to brain hypoperfusion and over-transfusion might lead increased intracranial tension. All these factors make fluid management in these procedures complex and challenging. Evidence on the optimum protocol for intraoperative fluid management in neurosurgical patients is still lacking.

Goal-directed therapy (GDT) in the operating room is a term used to describe the use of cardiac output or similar parameters to guide intravenous fluid and inotropic therapy.

Although GDT was well reported in many procedures, its benefit in neurosurgical operations is not well studied.

Pulse pressure variation (PPV) is a famous dynamic method of fluid responsiveness. PPV is simply calculated by dividing the largest pulse pressure (PPmax - PPmin) by the average pulse pressure (PPmax + PPmin /2) and expressed as percentage. PPV was previously used in GDT in major abdominal surgery with good performance.

The aim of this study is to compare the restricted fluid approach (1 ml/Kg/hr) guided by PPV to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision. The investigators hypothesize that in these procedures GDT might improve brain relaxation, and patient hemodynamics intra and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for supratentorial mass excision will be enrolled in the study.

Exclusion Criteria:

* Patients with arrhythmias, pulmonary hypertension, impaired cardiac contractility, impaired liver or kidney function, and patients with BMI above 40 will be excluded.
The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation

The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.

Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.

This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.

This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnosis of Rome III criteria for chronic functional constipation;
* severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months;
* 18-75 years old;
* no use of medicine for constipation during the two weeks before enrollment (except rescue medication);
* no acupuncture treatment for constipation in recent 3 months;
* never joined any other trial in process in 3 months;
* volunteered to join this research and signed the informed consent.

Exclusion Criteria:

* Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs;
* constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment;
* pregnant women or women in lactation period
* constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;
* bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera;
* cardiac pacemaker carrier.
Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.

The purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. The procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 or older
* Willing and able to provide informed consent for participation in the study.

Exclusion Criteria:

-
Effects of Low Tidal Volume and Airway Pressure Release Ventilation on Lung Tissue Mechanics in ARDS Patients Under Mechanical Ventilation: A Prospective Randomized Crossover Study

The goal of this clinical trial is to learn how low tidal volume ventilation (LTV) and airway pressure release ventilation (APRV) affect lung tissue mechanics in adults with ARDS. The main questions it aims to answer are:

Does LTV or APRV improve lung tissue mechanics in patients with ARDS under mechanical ventilation? Researchers will compare LTV and APRV to see which ventilation mode works better for improving lung mechanics and patient safety.


Eligibility Criteria:
Inclusion Criteria:

1. Meets the diagnostic criteria of the 2023 Global New Definition of ARDS.
2. Age: 18-80 years.
3. PaO2/FiO2 ≤ 200.
4. Within 12 hours of invasive mechanical ventilation treatment.
5. Obtain consent from the patient or their family members to participate in the study, and sign the informed consent form.

Exclusion Criteria:

1. Age \< 18 years or \> 80 years.
2. Uncorrected shock of any type.
3. Chronic obstructive pulmonary disease (COPD), pulmonary embolism, right heart failure, pulmonary hypertension, or severe arrhythmia.
4. Contraindications for using Electrical Impedance Tomography (EIT) (extensive chest skin damage, infection, pacemaker implantation, implanted automatic defibrillator, etc.), pneumothorax, mediastinal emphysema, or large pleural effusion.
5. Pregnant or breastfeeding women.
6. Patients planned for ECMO treatment.
7. Patients currently participating in or previously enrolled in other clinical studies.