cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).

Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.

For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.

The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participant has confirmed diagnosis of Ulcerative Colitis (UC) for at least 3 months prior to Baseline.
* Participant has active UC with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
* Participant has demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), and immunomodulators.

Exclusion Criteria:

* Participant has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab.
* Participant with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis.
* Currently known complications of UC such as: fulminant colitis and/or toxic megacolon, acute severe UC, previous colectomy (total or subtotal), or any other manifestation that might require surgery while in the study
* Active systemic infection/clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator.
Pulmozyme for Sjogren's Associated Cough

Patients with Sjogren's disease have destruction of the mucus secreting cells in the airway. This manifestation of the disease leads to the common complaint of persistent dry cough that is seen in many of these patients. This study is aimed at determining whether the regular use of Pulmozyme will result in decreased cough and improved quality of life.

Patients with Sjogren's disease have destruction of the mucus secreting cells in the bronchi. This manifestation of the disease leads to the common complaint of persistent dry cough that is seen in many of these patients. The investigators theorize that regular use of Pulmozyme will result in decreased cough and improved quality of life, by improving mucus clearance.

Primary Objective:To determine if the use of Pulmozyme, twice a day improves cough-related quality of life or cough severity in patients with chronic cough due to Sjogren's disease.

Secondary Objectives:

1. To determine the DNA content in sputum from patients with chronic cough due to Sjogren's disease.
2. To determine the effect of Pulmozyme use on pulmonary function in patients with chronic cough due to Sjogren's disease.
3. To determine the safety of Pulmozyme, taken twice a day in patients with chronic cough due to Sjogren's disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above with primary Sjogren's disease (as defined by the American European Consensus Group Criteria), and complaint of chronic cough.
* Able to give consent and anticipated ability to adhere to the study procedures.

Exclusion Criteria:

* Diagnosis of COPD, emphysema, asthma, chronic bronchitis, other clinically significant lung disease that is likely to cause cough. Interstitial lung disease associated with Sjogren's is not excluded.
* Cigarette use of greater than 20 pack years or regular use within 6 months
* Allergy or intolerance to Pulmozyme.
* Acute respiratory infection or other acute respiratory illness during the prior month.
* LCQ greater than 17 and VAS less than 3 cm at baseline (Visit 1).
* Pregnancy or breast feeding.
3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenia (CM)

Lambert-Eaton Myasthenic Syndrome (LEMS) is a rare autoimmune disorder which affects the nerve-muscle junction. The major symptoms of LEMS are progressive muscle weakness. Many patients experience other symptoms like dry mouth or impotence. Congenital Myasthenia (CM) is an inherited disorder with similar affects and symptoms.

3,4-Diaminopyridine (DAP) is an experimental drug that has improved strength in some subjects with (LEMS). There are no other accepted treatments for LEMS and DAP has relatively few side effects.

Subjects with clinically confirmed LEMS or CM will receive 3,4-diaminopyridine (3,4 DAP) by mouth in slowly increasing doses. Treatment will begin with 5-10 mg three times a day. A common final dosage is 15-20 mg four or five times a day, as clinically needed, and if tolerated. The upper limit is a total of 100 mg/day. Subjects will be monitored for strength and side effects via routine clinic visits at intervals of one month for the first three months, then every three months for the first year, and at least every six months thereafter. Treatment will be continued indefinitely if a good clinical response is achieved and side effects are tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of LEMS or CM
* If female and over the age of 9, must have a negative pregnancy test, and, if premenopausal, must be willing to practice an effective form of birth control.
* Must be tested and found by ECG not to have a prolonged Q-Tc syndrome.
* Must agree to have a second ECG at the time of peak drug effect.

Exclusion Criteria:

* Known to have sensitivity to 3,4-DAP
* History of clinical seizures or evidence of seizure activity on screening EEG
* History of severe asthma
Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy People

Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in healthy, recreational sportspeople and to assess the safety of the product


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers between 18 and 40 years old
* Females must test negative for pregnancy
* Recreational athletes according to the american college of sports medicine (ACSM) definition
* Familiar with the cycle ergometer exercise methodology
* Written inform consent according to good clinical practice (GCP) and local regulations

Exclusion Criteria:

* Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
* Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report
* Smokers
* Known hypertension
* Known hypercholesterolemia (moderate/severe)
* Female volunteers taking oral or injectable contraceptives
* Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills \[intrauterine devices (IUDs)\]
* Pregnancy and/or lactation
* Liver and/or renal disease and/or vascular disease
* Relevant allergy or known hypersensitivity to the investigational drug or its excipients
* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial

This is a prospective, controlled, randomized trial. Primary objective is to compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. 70 Eligible subjects will be identified from within the patient population of the study site. There will be no advertisements for study subjects.

Primary Objective:

To compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo.

Secondary Objective:

To evaluate the following secondary outcomes:

* Anxiety score (HADS) in preoperative holding area
* Midazolam use intraoperatively (mg)
* Itraoperative opioid use (morphine equivalents)
* Intraoperative anti-emetic use
* Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU
* Rate and intensity of PONV in PACU
* Antiemetic use in PACU
* Opioid use in PACU (morphine equivalents)
* Pain intensity in PACU (0-10 numerical rating scale)
* Patient satisfaction in PACU

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old)
* Port-a-Cath placement under Monitored Anesthesia Care
* Signed informed consent

Exclusion Criteria:

* Patients undergoing other surgical procedures during Port-a-Cath placement (including explantation of a Port-a-Cath or other previous vascular access device)
* Patients requiring general anesthesia or those not eligible for MAC
Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin

The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, regardless of gender.
2. History of penicillin allergy.
3. Helicobacter pylori infection.
4. Patients who have not previously received Helicobacter pylori eradication therapy.

Exclusion Criteria:

1. Medication history of bismuth and antibiotics within 4 weeks; PPIs and P-CABs within 2 weeks.
2. Serious underlying diseases, such as liver insufficiency, renal insufficiency, malignant tumors, etc.
3. Previous gastric or esophageal surgery.
4. History of allergy to test drugs.
5. Pregnant and lactating women and those unwilling to use contraception during the trial period.
6. Have other behaviors that may increase the risk such as alcohol and drug abuse.
7. Those unable to provide informed consent.
Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease

The goal of this clinical trial is to exploring the changes in 24-hour urinary protein and renal function in obese patients with kidney disease after the application of sodium glucose cotransporter 2 inhibitors (SGLT2i) and glucagon like peptide-1 receptor agonists (GLP-1RA).

Eligible patients were randomly and non-blindly allocated to four groups in a 1:1:1:1 ratio.The first group is the optimized treatment group, and patients in this group maintain the maximum dose/maximum tolerated dose of RAS blocker therapy.

The second group is the optimized treatment + SGLT2i group. Participants in this group are titrated to the target dose (10 mg qd) in combination with dapagliflozin on the basis of optimized treatment.

The third group is the optimized treatment + GLP-1RA group. Participants in this group will be titrated to the target dose (1mg qw) in combination with semaglutide on the basis of optimized treatment.

The last group is the optimized treatment + SGLT2i + GLP-1RA treatment group, that is, based on the optimized treatment, combined with dapagliflozin titrated to the target dose (10 mg qd) and semaglutide titrated to the target dose (1 mg qw).


Eligibility Criteria:
Inclusion Criteria:

1. Agree to join this study and sign an informed consent form;
2. Age ≥ 18 years old and\<75 years old;
3. BMI ≥ 25kg/m ² Or waist circumference ≥ 85cm (male)/≥ 80cm (female) or waist to hip ratio ≥ 0.9 (male)/≥ 0.85 (female);
4. Confirmed obesity related kidney disease through renal biopsy within six months;
5. Have received optimized treatment with RAS blockers and/or MRA for at least 3 months;

Exclusion Criteria:

1. Diagnosed as secondary obesity, such as hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc;
2. Severe renal insufficiency (renal function eGFR\<25 ml/min/1.73m2);
3. There is acute kidney injury; Defined as: (1) An increase in blood creatinine of ≥ 26.5 within 48 hours μ Mol/L; (2) Within 7 days, the increase in blood creatinine exceeds 1.5 times the baseline value or more; (3) Reduced urine output (\<0.5 ml/kg/h) and lasting for more than 6 hours.
4. Symptoms of active reproductive and urinary system infections
5. Severe liver dysfunction (ALT/AST greater than 2.5 times the upper normal limit);
6. Severe cardiovascular and cerebrovascular diseases, rheumatic and immune diseases;
7. Serious metabolic diseases, such as diabetes ketoacidosis, hypertonic hyperglycemia, etc;
8. Late stage malignant tumors;
9. Have a known history of using drugs that affect glucose and lipid metabolism, such as glucocorticoids, antibiotics, anti anxiety or antidepressants, etc;
10. Severe bleeding tendency and inability to complete venous blood collection;
11. There are contraindications for MRI examination, such as patients with pacemakers, nerve stimulators, artificial metal heart valves, etc; Patients with claustrophobia; Epilepsy patients, etc.
12. Pregnant/lactating women;
Traditional Thai Massage and Brain Electrical Activity

The purpose of this study is to evaluate the immediate effect of traditional Thai massage on brain electrical activity in the patients with scapulocostal syndrome


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 - 50 years old
2. The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and trapezius muscles). Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
3. The participants will be able to follow instructions.
4. Good communication and cooperation.

Exclusion Criteria:

1. A history of the following diseases or disorders:

   * Rotator cuff disease
   * Cervical radiculopathy
   * Degenerative shoulder joint disease
   * Shoulder stiffness
2. Contraindications of traditional Thai massage

   * Contagious skin disease
   * Injury or inflammation of muscle
   * Bone fracture and/or joint dislocation
   * Open wound
   * Uncontrolled hypertension
   * Drug and/or alcohol intoxication
Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD

To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection prophylaxis prior to and/or following transplant of MA09-hRPE cells.

This study will be a Phase 2, double-masked, randomized, parallel group, sham surgery/placebo control, multi-center trial. Subjects will be randomized in a 3:1 ratio to either the treatment or control group respectively. Subjects randomized to the treatment group will receive transplantation with 200,000 MA09-hRPE (human embryonic stem cell derived retinal pigmented epithelial)cells in one eye. Subjects randomized to the control group will have a sham surgery without transplantation of MA09-hRPE cells. The study eye must meet all eligibility criteria. If both eyes meet all eligibility criteria, then the study eye will be the eye with the worst Best Corrected Visual Acuity (BCVA) score at screening. If both eyes have identical BCVA scores, then the study eye will be chosen by the Investigator and the subject. There will be 3 cohorts, each with a different regimen of low-dose IMT \[tacrolimus and mycophenolate mofetil (MMF)\]. Subjects will be randomized to treatment or control within cohorts, defined by severity of BCVA in the study eye at Screening. Enrollment in Cohort 1 and 2 will be concurrent. Enrollment into Cohort 3 will begin once Cohort 2 is fully enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Geographic atrophy (GA) secondary to AMD with no evidence of prior to active choroidal neovascularization (CNV) in the study eye.
* BCVA in the study eye must be between 4 and 58 Early Treatment of Diabetic Retinopathy Study (EDTRS) letters (20/800 to 20/80; 0.025-0.25)
* Subjects must be willing to take IMT and willing to discontinue any medication that has a known strong interaction with tacrolimus or mycophenolate mofetil (MMF)

Exclusion Criteria:

* Macular atrophy due to causes other than AMD
* Other sight-threatening ocular disease
* Current or prior history of optic neuropathy, retinal dystrophy, retinitis pigmentosa, chorioretinitis, vasoocclusive disease, retinal vascular disease or retinal degenerative disease OTHER than AMD
* History of uveitis
* History of allergic reaction to sulfa drugs
* Solid organ or bone marrow transplant recipient
* History of malignancy within the previous 5 years (except for BCC (basal cell carcinoma), SCC (squamous cell carcinoma) or in-situ cervical)
* History of myocardial infarction with past 12 months
* History of clinically significant cardiac dysrhythmia
* History of diabetes mellitus, bowel disease, tuberculosis
* Prior treatment for non-exudative AMD
* Intraocular, refractive or cataract surgery in the last 12 weeks
* Prior retinal surgery, vitrectomy, macular laser photocoagulation, external beam radiation therapy, transpupillary thermotherapy, glaucoma filtration surgery or corneal surgery (except cataract surgery)
* Receipt of gene transfer of cell transplant therapy in a prior clinical trial
* Participation in any other interventional clinical trial within the last 12 weeks
Safety, Tolerability, PK, and PD of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR

Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral effects on weight in obese and diabetic rodent models. Results from a Phase 1b clinical study, conducted in healthy volunteers, indicate that LIM-0705 and a major metabolite may be potential insulin sensitizers by OGTT.

The primary objective of the study is to evaluate the safety and tolerability of LIM-0705 administered for 28 days in adult males and females with impaired glucose tolerance or abnormal HOMA-IR.

Secondary Objectives include:

* examine the pharmacokinetics (PK) of LIM-0705
* explore the pharmacodynamics (PD) of LIM-0705 in obese adult males and females with impaired glucose tolerance (defined as two-hour plasma glucose levels of ≥140 to ≤199 mg per dL \[7.8 to 11.06 mmol/L\] on the 75-g oral glucose tolerance test \[OGTT\]) or abnormal HOMA-IR (HOMA-IR value ≥ 2.5) as measured by change in response to hyperinsulinemic clamp, mixed-meal tolerance test (MMTT) between Days -2 and 27
* explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels

Eligibility Criteria:
Inclusion Criteria:

* males and females, age 18-75 years old, able and willing to provide written informed consent to participate in the study
* obesity-induced impaired glucose tolerance or abnormal HOMA-IR
* waist circumference of 40 inches or greater (men) or 35 inches or greater (women)
* good physical health based on EKG, electrolytes, LDH, creatinine, urea, AST, ALT, alkaline phosphatase, and renal function
* male subjects who are sexually active with a female partner of childbearing age must agree to use of 2 effective methods of contraception, including the use of a condom, throughout the course of the study or provide proof of surgical sterility. The second method of contraception must be the use by their female partners of any of the following: a diaphragm with spermicide, a cervical cap with spermicide, an IUD, a female condom, or an approved hormonally based contraceptive (e.g., an oral, transdermal, or implanted estrogen or progestin). Female subjects must be post menopausal or surgically sterile.

Exclusion Criteria:

* BMI equal to or greater than 40 kg/m2
* allergy to onions or red wine
* strict vegetarians
* use of any non-study medications other than thyroid replacement hormone or anti-hypertensives. Use of cardesarten cilexetil is not permitted. Note: acetaminophen should not be administered.
* use of chemotherapy agents or history of cancer, other than non-metastatic non-melanoma skin cancer that has been completely excised, within 5 years prior to the screening visit
Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis

The intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes.

This will be an open-label, non-randomized multi-center patient sponsored study of ADSC implantation using an IV delivery system. The study will provide therapies to up to 100 qualified patients who match the inclusion/exclusion criteria, agree to the follow up program and who have provided a signed consent for each procedure.

The treatment is a combination of (a) general detoxification, (b) lymphatic massage/drainage, (c) therapeutic massage, reflexology and acupuncture and (d) cellular infusion therapy in which cells will be deployed via IV injection over two treatments of 60 minutes each during the five (5) day treatment period.

Follow-up data based upon MSIS-29, a modified SF-36 and standard complication questionnaire will be collected at 3, 6 and then annually post treatment by the patients' local physician and reported back to the sponsor where it will be logged into a HIPPA-compliant outcomes database.

Additional safety data, based upon a standard complication questionnaire will be collected via survey of patient at intervals of 3 and 6 months and then annually for a minimum of five (5) years.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Diagnosis of MS
* Aged 18 - 65 years.
* Duration of disease: \>5 years
* Signed, written informed consent willing and able to comply with study visits according to protocol for the full study period
* Physically, mentally and legally capable of international travel for treatment

Exclusion Criteria:

* Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
* Patient with any active or chronic infection
* No life-threatening organ dysfunction.
* Pregnancy or risk of pregnancy.
* Severe physical limitations or disabilities
* Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
* Patients unable to give written informed consent in accordance with research ethics board guidelines
* Treatment with any immunosuppressive therapy within the 3 months prior to randomization
* Current treatment with an investigational therapy