cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of KarXT + KarX-EC capsules versus KarXT capsules in healthy adult and elderly participants of Japanese ethnicity and to assess the effect of multiple doses of omeprazole on the exposure of xanomeline and trospium administered as KarXT + KarX-EC capsules in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria

* Inclusion Criteria for Healthy Adult Japanese Participants (Group A):.
* Healthy adult participants must be 19 to 55 years of age, inclusive.

  i) Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese.

ii) Must have a body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF.

iii) Must have an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min/1.73m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the screening visit. One repeat measurement is allowed.

* Inclusion Criteria for Healthy Elderly Japanese Participants (Groups B and C):.
* Healthy elderly participants must be 56 to 90 years of age, inclusive.

  i) Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese.

ii) Must have a BMI ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive), at the time of signing the ICF.

iii) Must have an eGFR of \> 60 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed.

* Inclusion Criteria for Healthy Adult Participants (Groups D):.
* Healthy adult participants must be 19 to 55 years of age, inclusive.

  i) Participants with any ethnicity can be included.

ii) Must have a BMI of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF.

iii) Must have an eGFR of ≥ 90 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed.

Exclusion Criteria

- Exclusion Criteria for All Participants (Groups A, B, C, and D):.

i) Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.

ii) History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.

iii) Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.

iv) History of cancer that has not been in full remission for \>5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for \> 1 year prior to the screening visit).

* Other protocol-defined Inclusion/Exclusion criteria apply.
Effects of Oral Tranexamic Acid on Short Term Postoperative Outcomes Following Total Shoulder Arthroplasty

The purpose of this clinical trial is to evaluate the short-term clinical outcomes of patients undergoing total shoulder arthroplasty who receive an extended postoperative course of oral tranexamic acid


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients (ages 18-79) undergoing primary total shoulder arthroplasty

Exclusion Criteria:

* Patients with Cancer, venous thromboembolism, stroke, heart disease, pregnant or nursing, allergic to TXA, current tobacco use, anticoagulants other than aspirin.
A Study of RO6799477 in Healthy Volunteers

This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male healthy volunteers, aged 18-45 years, inclusive
* Male volunteers with female partner of childbearing potential must agree to use an effective form of birth control during the study and for 3 months after discontinuation of treatment.
* Body Mass index (BMI) of 18-30 kg/m2, inclusive

Exclusion Criteria:

* Infection with human immunodeficiency virus antibody (HIV 1 and 2), Hepatitis B, hepatitis C
* Positive testing for drugs of abuse
* Any history of alcohol and/or drug of abuse addiction
Tajik Migrant Health Education Study

This study will test the efficacy of a peer-education prevention intervention to reduce risky drug, alcohol, and sexual behaviors among male Tajik labor migrants who inject drugs (MWID) while working in Moscow. The peer educator intervention will be compared to a health education control intervention. Each intervention consists of 5 weekly 2-hour small group sessions. Follow-up assessments will be conducted at 3, 6, 9, and 12 months after the intervention. It is hypothesized that, compared to MWID who receive the health education control intervention, those who receive the peer educator intervention will have a greater reduction in the frequency of risk behaviors. Similar effects are expected for network members of intervention participants.

The investigators will recruit male Tajik migrants who inject drugs from 12 different sites in Moscow, including bazaars and other work sites. In both study arms, the recruited men (index participants) will be required to recruit two eligible MWID peers for interviews prior to being interviewed themselves. Participants will be randomly assigned to either the peer educator intervention program or the health education intervention program. After peer-recruited network members are enrolled and interviewed, the index participant will participate in the peer educator training or the control group activities. All participants and recruited network members will then be followed and re-interviewed at 3-month intervals for one year to assess changes in risky drug, alcohol, and sexual behaviors due to intervention participation and through diffusion to network members. The investigators will also collect data from voluntary HIV and HCV testing conducted at 6 months (HCV only) and at 12 months (HIV and HCV) post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* adult Tajik man
* injected drugs in past 30 days
* living and working as migrant laborer in Moscow

Exclusion Criteria:

* does not intend to stay in Moscow for the next 12 months
Status of Management of Surgery in Beijing During COVID-19

This is a multi-centered, retrospective, observational study aimed at observing the current status of the management of gastrointestinal surgery during the COVID-19 pandemic, particularly the changes on surgery protocols and other key aspects of surgical workflow, so as to share experience with colleagues both domestic and abroad.


Eligibility Criteria:
Inclusion Criteria:

* All patients arriving at surgical emergency and all patients receiving gastrointestinal surgeries in participating centers from 2020.1.1\~2020.3.31.

Exclusion Criteria:

* None
Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease

Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives

The effect of Carvedilol CR on Micro T-Wave Alternans will be assessed in 30 hypertensives with stage 4 or 5 chronic kidney disease utilizing a cross-over design and contrasting no treatment against active treatment periods of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and older
* Chronic kidney disease
* Must be able to do stress test

Exclusion Criteria:

* Must not be mentally disabled
* Unable to provide informed consent
* Unable or unwilling to comply with study protocol or procedures
* Pregnancy or unknown pregnancy status in female of childbearing potential
* Participation in any drug trial during the study period
* Prior enrollment in this study
* Active liver disease
* Currently on β-blocker medication at the time of enrollment
* Known history of asthma exacerbation with β-blocker therapy
* Second or third degree AV nodal block or bradycardia with resting heart rate \<50 bpm
* Prior allograft organ transplantation
* Planned allograft transplantation reasonably foreseen within the active treatment period
* Electrocardiographic left or right bundle branch block
* Permanent implanted pacemaker
* Atrial fibrillation
* Ongoing treatment with any of the following medications: sotalol (Betapace), azimilide (Stedicor), quinidine (Quinidex), disopyramide (Norpace), dofetilide (Tikosyn), ibutilide (Corvert), procainamide (Procanbid), bepridil (Vascor), amiodarone (Cordarone), clarithromycin (Biaxin), erythromycin (Eryc), halofantrine (Halfan), pentamidine (Pentam), sparfloxacin (Zagam), domperidone (Motilium), droperidol (Inapsine), chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), thioridazine (Mellaril), pimozide (Orap), arsenic trioxide (Trisenox), cisapride (Propulsid), lidoflazine (Clinium), and methadone (Dolophine)
A Study to Investigate the Effect of SB-705498 on Chronic Cough

This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 30 -75 (Part A) and 18-75 (Part B) years of age inclusive.
* Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
* Non-smoker for at least 6 months with a pack history \<5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
* Body weight \> 50 kg and body mass index (BMI) within the range 19 - 30.0 kg/m2 (inclusive).
* Capable of giving written informed consent.
* Agree to use contraception listed as acceptable
* Normal 12-lead ECG at screening.
* Chronic cough (Part B only)
* Good general health, apart from chronic cough (part B only), as determined by a responsible physician.

Exclusion Criteria:

* A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
* Positive pre-study drug/alcohol screen.
* Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
* A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
* History of regular alcohol consumption within 6 months of the study.
* Exposure to more than four new chemical entities within 12 months prior to the start of the study.
* Participation in a clinical trial with a new molecule entity or any other clinical trial within 30 days of the start of the study.
* Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to study.
* known history of lung cancer
* current treatment with oral corticosteriods or other immunosupressive agents
* FEV1 less than 80% of predicted value at screening
* Any subject who does not reach C5 following 250uM oral capsaicin
* History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
* Donation of blood or blood products in excess of 500mL within a 56 day period prior the start study.
* Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
* Lactating females.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to dosing.
Effect of Metformin on Exercise-induced Lipolysis

The aim of this study is to investigate whether metformin has inhibitory effect on exercise-induced lipolysis in subcutaneous adipose tissue in healthy lean man. Ten healthy lean mean will follow protocols consisting of 60 minutes of exercise on bicycle ergometer combined with a) orally administered metformin and b) locally administered metformin into adipose tissue and c) without metformin treatment. Microdialysis is used for assessment of metabolites in situ in subcutaneous adipose tissue.

Metformin and physical activity are often recommended as the first therapeutic agents to improve glycemic control for prediabetes and type 2 diabetes (ADA). It has been reported that metformin decrease plasma concentration of non-esterified fatty acids in patients with type 2 diabetes which might be associated with the inhibition of lipolysis in adipose tissue. However, the inhibition of lipolysis during physical exercise, would not be probably beneficial. Thus, the effect of metformin on lipolysis during exercise is investigated in this protocol. As the lipolysis regulation is often impaired in obese and diabetic patients, the healthy lean men were chosen for this pilot study. Glycerol will be analyzed as a measure of lipolytic rate in adipose tissue and in plasma. Lactate levels will be observed. Our findings should provide a new background about the combination of physical activity and metformin medication.

Eligibility Criteria:
Inclusion Criteria:

* healthy lean men, non obese, BMI 20-28 kg/m2

Exclusion Criteria:

* weight change within the 3 months before the study,
* hypertension,
* impaired fasting glucose
* diabetes
* hyperlipidemia
* drug or alcohol abuse
* smoking
Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke

A multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This phase of study is visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for autologous stem cell therapy in patient with acute ischamic stroke.

This phase of the study will have two arms developed through random allocation: one arm for intravenous autologous bone marrow derived stem cell/mononuclear cells(BMMC arm); and second control arm. Patients with acute ischaemic stroke between 7-30 days after onset with moderae severity in sable condition will be entered into the study after informed consent. Both arms will receive standard treatment but BMMC arm will,in addition,have bone marrow aspiration and receive autologous 30-500 million bone marrow mononuclear cells intravenously on the day of randomisation and all patients will be followed at DaY 7 ± days, Day 90(-7 days to +14 days), Day 180(-7 days to +28 days)and Day 365 (-7 days to + 28 days). A number of safety and efficacy variables will be measured. This phase 2 study will aim to determine dose response gradient of stem cell therapy and to explore if results have a favourable risk to benefit ratio to justify a phase 3 study. This will be the first human trial to determine and compare favourable and unfavourable effects of bone marrow mononuclear cells(mainly CD34) in acute ischamic stroke and also the first multi-centric study with potential to achieve a reasonable sample size in a relatively short time.

Eligibility Criteria:
Inclusion Criteria:

1. Sudden onset of focal neurologic deficit or impairment of consciousness.
2. CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory.
3. Age between 30 -70 years (after amendment 18 -70 years).
4. \>7 to \</=30 days passed since the onset of the qualifying event.
5. Glasgow Coma Scale score of \>8 at the time of randomization, in aphasic Eye and Motor score of \>6.
6. Modified Barthel Index score of 50 or less at the time of randomization.
7. NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree.
8. Patient is stable. ( normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \< 200 mg% and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria: -

1. Lacunar syndrome
2. Intubation
3. Posterior circulation stroke
4. Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure.
5. Inaccessibility for follow up.
6. Allergy to local anaesthetic.
7. Unwillingness to provide written informed consent.
8. Symptom of acute myocardial infarction or acute involvement of any other organ.
9. Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months.
Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Losartan Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at screening
* Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN
* Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
* eGFR ≥15 mL/min/1.73 m2, calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
* No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy
* Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization
* Have received required vaccinations against N. meningitidis, S. pneumoniae, and H. influenzae (type B) or agree to receive vaccinations, if applicable vaccination records are not available. Vaccination is mandatory unless documented evidence exists that subjects are non-responders to vaccination.

Exclusion Criteria:

* Absolute neutrophil count \<1000 cells/mm3 during screening
* Previous treatment with pegcetacoplan
* Evidence of rejection on the screening renal allograft biopsy that requires treatment
* Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection with any of these viruses
* Weight more than 100 kg at screening
* Hypersensitivity to pegcetacoplan or any of the excipients
* History of meningococcal disease
* Malignancy, except for the following:
* Cured basal or squamous cell skin cancer
* Curatively treated in situ disease
* Malignancy free and off treatment for ≥5 years
* Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection, or a medication) that would, in the opinion of the investigator, confound interpretation of the study results
* Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening
* Known or suspected hereditary fructose intolerance.
Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy

The purpose of this research study is to learn more about the usefulness of a physical therapy treatment that combines robot-assisted walking with electrical impulses that help to make muscles contract. This treatment is intended for children with cerebral palsy. Up to eleven children with cerebral palsy will receive up to 18 treatments and will have several evaluations before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* GMFCS II, III, or IV cerebral palsy
* 5-12 years of age
* meet safety criteria for robotic gait training (\<300 lbs, intact skin, femoral length 21-47 cm, ability to follow simple instructions)
* meet safety criteria for functional electrical stimulation (voluntary hip and knee muscle contraction, intact skin)

Exclusion Criteria:

* planned major intervention during study period
* contractures that interfere with upright stance
* history of non-traumatic long bone fracture or clinically significant osteoporosis
* significant concurrent illness
* significant condition not typically associated with cerebral palsy
Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan

The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing frozen thawed ET cycles
2. Patient has at least two embryos suitable for transfer after thawing
3. Age 18-35 years -

Exclusion Criteria:

1. Any known sensitivity to Endometrin or Utrogestan
2. Endometrial thickness less than 7.5 mm after estrogen priming -
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness

The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female subjects (40 years of age and older).
* Patients with diagnosis of COPD according to the GOLD guidelines.
* Post-bronchodilator FEV1 \<80% of the predicted value at the screening visit.
* Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit.
* Current or former smokers (e.g., with history of = 10 pack-years).
* Written informed consent.

Exclusion Criteria:

* Known respiratory disorder other than COPD including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
* History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
* Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit.
* Treatment for COPD exacerbation within 12 weeks prior to the screening visit.
* Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 6 weeks prior to the screening visit.
* Abnormal and significant ECG finding prior to the screening, during the run-in and treatment periods.