cyrilzakka/clinical-trials huggingface dataset:
Effects of Osteopathic Visceral Manipulation on the Autonomic Nervous System, Balance and Gastrointestinal Disturbances in Individuals With Parkinson's Disease

Introduction: Parkinson's disease (PD) is responsible for several changes in the body, such as balance, gastrointestinal and autonomic disorders and are associated with impairments in the clinical prognosis of these individuals. In this sense, therapies capable of minimizing this impact are extremely important. Osteopathy has become an alternative treatment for individuals with neurological disorders and has been shown to be effective in treating various conditions, including PD. Objective: a) to evaluate the acute effect of visceral manipulation directed to the intestines and visceral plexuses in the autonomic nervous system of PD patients; b) identify the effect of this approach, after four visits, on balance, plantar pressure, gastrointestinal disorders and autonomic nervous system in this population. Materials and Methods: For this randomized clinical trial, 28 adults diagnosed with PD will be recruited. Subjects will be randomized to protocols in two groups: intervention protocol and placebo protocol, where both will consist of 4 visits twice a week. The intervention protocol will consist of osteopathic manipulative techniques and the sham protocol will consist of simulation of therapy, where the therapist will place his hands in the same regions of the intervention protocol, with superficial contact and without therapeutic intention in each region. The outcome measures of the study will consist of Berg balance assessment and plantar pressure, Rome survey on gastrointestinal disorders, and assessment of autonomic modulation by means of heart rate variability analysis. Volunteers and evaluators will be blind to the protocol and not informed of their order. Only the person responsible for the intervention will not be blind to the protocol. Data will be analyzed according to normality (Shapiro-Wilk test), and comparisons of outcomes between the moments (pre and post) will be performed using the T-student test for paired data or Wilcoxon, as normal and for comparisons between protocols. placebo and intervention, Student's T-test for unpaired data or Mann-Whitney test according to normality will be applied. The adopted statistical significance will be fixed at 5%.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's;
* Not having cardiorespiratory diseases;
* Not being a smoker;
* Do not use alcoholic beverages;
* No cognitive deficit;
* No osteoarticular deformities, plantar ulcers, total or partial amputation of the feet;
* They do not need auxiliary devices for walking

Exclusion Criteria:

* Data from individuals with a series of heart rate intervals with less than 95% of sinus beats will be excluded from the study.
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia

Patients suffering from acute renal colic are evaluated by non contrast computerized tomography with excellent identification rates of urinary stones. The scan also covers the bones of the ribs, spine and pelvis, allowing measurements of the bone density and identifying early osteopenic changes. Bone demineralization is associated with metabolic changes such as hypercalcemia or hypercalcuria. In this study the investigators will look for correlation between kidney stones, osteopenic bone changes and metabolic abnormalities.

Kidney stones are a common medical condition found in more then 5% of the adult population. The stones might cause severe pain (due to acute obstruction of a renal unit) , deterioration of renal function and urinary tract infection. One of the causes of kidney stones is metabolic changes such as hypercalcemia or hyperoxaluria. Basic evaluation of kidney stones patients include measurements of calcium, phosphor and uric acid in the serum and is often negative. Thorough metabolic workup including 24 hours urine collection is not cost effective and is reserved for patients with frequent recurrence of stone disease.

Metabolic abnormalities are often associated with bone demineralization, of which the patients are typically unaware. such changes can be detected by the CT scan. On the same scan, performed for identifying the stone, the radiologist can measure bone density, using the Hounsfield units, in the L2 vertebral body of and the acetabular area of the pelvis.

In the study, in all patients undergoing CT scan due to renal colic, the bone density will be measured. Patients with abnormal bone density will undergo a complete metabolic workup including 24 hours collection of urine and measurements of urinary clearance of calcium, phosphorous, uric acid, oxalate and citrate . The investigators will look for correlation between osteopenic changes and metabolic abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or old
* informed consent
* kidney stones
* CT scan positive for stones AND bone changes

Exclusion Criteria:

* under 18
* unable to sign
* no stones detected on scan (even if a stone was expelled recently)
* no bone changes
* pregnancy
* a patient already known to suffer from metabolic bone disease
* a patient with documented osteoporosis
* patients following spinal or pelvic trauma / surgery
Lung HIV Microbiome Project (Michigan Site)

In its original phase, this cohort study recruited subjects who were either HIV-positive or HIV-negative healthy controls, to analyze the community structure of the lung microbiome. Original recruitment was planned to occur both at the University of Michigan Medical Center and clinics, and at VA Ann Arbor Healthcare System.

Enrollment for the original cohort is completed, and all current activity of this project is occurring at VA Ann Arbor, where both Veteran subjects and non-Veteran subjects are eligible to participate. This study is currently recruiting only healthy HIV-negative subjects. Participation, described below, involves a research bronchoscopy procedure.

This is a non-interventional cohort study with single time point cross-sectional comparisons and longitudinal analyses, with the primary study aims of: evaluating how the immune deficiency associated with HIV infection influences the lung microbiome and lung function, and evaluating changes in lung microbiota over time. The study also aims to characterize the microbiome of the lower respiratory tract, determine the relationship between the lower respiratory Microbiome and the upper respiratory and gastrointestinal tract microbiomes, evaluate the influence of smoking on the microbiome compared with the influence of smoking on pulmonary function and respiratory systems, and to evaluate how Pneumocystis infection influences HIV-infected and HIV-uninfected individuals.

Eligibility Criteria:
Inclusion Criteria:

* Negative HIV testing (by ELISA) during initial study visit
* No signs of respiratory infection at enrollment, such as: fever; recent change in quantity of quality of sputum; chest pain; recent change in shortness of breath or exertional activity
* Willing and able to sign the informed consent document
* If female of child-bearing potential, negative pregnancy test during initial study visit

Exclusion Criteria:

* Pregnancy
* Signs or symptoms of respiratory infection at enrollment
* Unwilling or unable to sign the informed consent document
* Unstable heart disease
* Other systemic disease and unlikely to survive at least 2 years
* Mental incompetence
* Participation in another interventional protocol within the last 6 weeks
* Use of antibiotics for a lung infection within the last 4 weeks
* Renal Failure (creatinine \>3)
* Child's Class C Cirrhosis
Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis

The primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).

The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function, biomarkers of inflammation and tissue damage, and the impact on overall health and perceived well-being and to evaluate the pharmacokinetics of BAY85-8501.


Eligibility Criteria:
Inclusion Criteria:

* Proven and documented diagnosis of non-CF (cystic fibrosis) idiopathic or post-infectious BE (bronchiectasis) by computed tomography (CT) scan \[conventional high resolution CT is considered the standard\], including 2 or more lobes and dilated airways compatible with BE at initial diagnosis
* Stable pulmonary status as indicated by the forced, expired volume in 1 second (FEV1) percent predicted ≥30% and \<90% (post-bronchodilator)
* Stable (i.e., no dose change) regimen of standard BE treatment administered at least for 4 weeks prior to screening
* Cough on most days

Exclusion Criteria:

* Forced, expired volume in 1 second \<30% or ≥90% predicted (post-bronchodilator)
* Recent significant hemoptysis (≥300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period)
* Known cystic fibrosis and/or documented chronic bronchial asthma
* Active allergic bronchopulmonary aspergillosis (ABPA)
* Diagnosis of common variable immunodeficiency (CVID)
* Systemic or inhaled antibiotic treatment within 4 weeks prior to screening
* Treatment of an exacerbation within 4 weeks prior to screening
* Systemic corticosteroids at \>10 mg/day prednisolone equivalent for \>2 weeks within 4 weeks prior to screening
Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.

Efficacy and safety evaluation of amiodarone and Nifekalant hydrochloride(NIF) for the treatment of ventricular tachycardia and ventricular fibrillation.

After patients are hospitalized, they will be treated as usual in addition to antiarrhythmic drugs. DC will be performed again according to normal procedures for patients who were ineffective. Arrhythmia drugs can only be used with nifekalant or amiodarone at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent ventricular tachycardia or ventricular fibrillation who have a combined physical heart disease, or who have a conventional drug ineffective or persistent idiopathic ventricular tachycardia with amiodarone indications;
* Age ≥ 18 years old, gender is not limited.

Exclusion Criteria:

* Patients with prolonged ventricular tachycardia with QT interval and patients with QTc interval of more than 500 ms before administration;
* Patients with torsades de pointes (Tdp);
* Patients with Brugada syndrome;
* Patients with severe atrioventricular block and without pacing protection;
* Patients with hypertrophic cardiomyopathy (HCM) with ventricular septal thickness or (and) left ventricular wall ≥ 15 mm;
* Pregnant or lactating women;
* Patients who are not suitable for the study, considered by investigators.
Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint (PADSTONE Study)

Acute-on-chronic liver failure (ACLF) is life-threaten syndrome in patients with chronic liver disease. In China, hepatitis B virus (HBV) is the main etiology of cirrhosis and HBV-ACLF is characterized by multiple organs failure (liver, coagulation and kidney, etc.) and associated with high risk of short-tern death. For the treatment of ACLF patients, recent studies investigated the efficiency of extracorporeal liver support, such as albumin dialysis, plasma exchange. However, the efficiencies remain unclear. Liver transplantation is the most efficient way to improve the survival of ACLF patients, especially for those patients with three or more organ failure.

More recently，an extracorporeal system which is called double plasma molecular absorption system (DPMAS) was applied for the treatment of ACLF patients. DPMAS is an extracorporeal procedure that combines two hemoperfusion machines. During the procedure, toxic plasma is separated and cleansed by perfusion over two absorbers, and the final cleansed plasma is then returned to patients. It does not require large volumes of plasma and nor does it bear the risk of plasma-associated allergic reaction or disease transmissions. PMAS can attenuate the jaundice in a short term and decrease the bilirubin concentration, which then reduces the toxicities of bile acid and high levels of bilirubin on the hepatocytes. Although DPMAS treatment is applied in the clinical practice for those patients with liver failure, it still lack of compelling evidence in terms of real efficiency.

Thus, in this prospective, multicenter and cluster-controlled study, the investigators aim to identify the optimal liver disease patients by using hard endpoints (short-term mortality and disease progression). Moreover, this study will collect biological samples, including plasma, urine and stool, to explore the precise profiling of ACLF patients with DPMAS therapy by multi-omics detection.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients
2. Age \>18 years
3. Chronic liver disease regardless of the etiology
4. Total bilirubin ≥ 12mg/dl and INR ≥ 1.5

Exclusion Criteria:

1. with more than three organ failures (SOFA criteria);
2. the pregnant;
3. with severe non-hepatic disease (such as chronic obstructive pulmonary disease level IV, chronic kidney disease with end-stage renal failure, myocardial infarction within 3 months before admission); 4) human immunodeficiency virus (HIV) infection without treatment;

5) patients with unstable hemodynamics caused by infection or acute bleeding; 6) hospital stays \<48 hours; 7) diagnosis of hepatocellular carcinoma during screening period; 8) for the DPMAS clusters: patients unwilling to receive DPMAS treatment alone or in combination with PE; 9) for the SMT clusters: patients plan to receive DPMAS therapy or other ALSS; 10) not suitable to participate in this study judging by researchers; 11) not sign the informed consent.
A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia

The primary objective of this study is to determine pilot safety and efficacy data for a topical formulation of EM-1421 applied to the cervix of patients with CIN 1, 2, or 3.

This was an open-label, pilot Phase I/II dose evaluation and pharmacokinetic evaluation study to compare the safety and efficacy of terameprocol (45mg or 90mg/application)administered once per week for 3 weeks to the cervix uteri in patients with biopsy-proven CIN. Patients who met eligibility criteria visited the clinic weekly for terameprocol application. Patients kept a daily diary card record of genitourinary symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Negative pregnancy test
* Biopsy confirmed CIN 1, 2, or 3

Exclusion Criteria:

* Pregnancy or breast feeding
The Relationship Between Serum Endocan and ADMA Levels and Penile Doppler Ultrasonography in Erectile Dysfunction

The gold standard diagnosis in patients admitted to the hospital with the complaint of erectile dysfunction is penile doppler ultrasonography. This procedure is an invasive procedure and can cause various complications. Therefore, in this study, we aimed to support and define the diagnosis of erectile dysfunction with some biomarkers that can be measured in blood samples. At this point, we performed penile doppler ultrasonography, which is the gold standard test, for all patients who applied with the complaint of erectile dysfunction, and compared the results of penile doppler and serum biomarkers in the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe erectile dysfunction according to International Index of Erectile Function-15 questionnaire
* Patients who have not received medical or surgical treatment before
* Patients without comorbidity and related drug use

Exclusion Criteria:

* Patients who have had previous pelvic trauma or surgery,
* Patients who have benefited from using phosphodiesterase-5 enzyme inhibitors,
* Patients with psychogenic erectile dysfunction and moderate or mild erectile dysfunction according to International Index of Erectile Function-15 questionnaire,
* Patients who have neurological disease, chronic liver disease and patients with chronic renal failure and those who used drugs that could cause erectile dysfunction
A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer


Eligibility Criteria:
Inclusion Criteria:

1. Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan;
2. At least 18 years old.
3. Primary colon adenocarcinoma was histologically confirmed.
4. Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
5. MSI-H or dMMR.
6. Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator.
7. Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria.
8. The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1.

Exclusion Criteria:

1. Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
2. Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) or any other drug acting on T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy.
3. Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
4. Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.
French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV

Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous pacemakers. The absence of atrial pacing has restricted their uses mainly for cases of paroxysmal atrioventricular block (AVB) or AVB with atrial fibrillation. The Micra AV contains an embedded accelerometer that senses the atrial contraction waveform, allowing the ventricle to be paced once the atrial contraction is complete. This atrioventricular synchronization is intended to extend the use of the device to cases of permanent complete AVB with normal sinus function. Two randomized clinicals trials have been proven it's efficacy. However, with AV-CESAR cohort, we aim to evaluate the real word effectiveness of Micra AV, in the first 1000 patients implanted by the device in France.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent Micra AV implantation

Exclusion Criteria:

* Refusal of consent
Evaluation of the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis

The current study aims at evaluating the effect of biofeedback of correct partial weight bearing on the rate of osseous non-union compared to conventional patient instruction without biofeedback.

Post-traumatic situations or instabilities of other aetiology at the level of the foot can lead to painful degenerative arthritis that necessitates surgical arthrodesis for pain relief. Surgical arthrodesis in this region though is associated with a high risk of osseous non-union (depending on the exact location up to 40%) despite standardized preparation and fixation techniques. The development of osseous non-union is associated with certain patient characteristics like active smoking, nutrition etc. Compliance to partial weight-bearing during the early postoperative phase is another contributing factor.

The current study aims at evaluating the effect of biofeedback of correct partial weight bearing on the rate of osseous non-union compared to conventional patient instruction without biofeedback.

All patients will postoperatively be provided with a lower- leg unloading orthosis furnished with a weight sensor that will - according to randomization - give feedback if a predefined weight threshold has been crossed or just measure weight-bearing without feedback.

Eligibility Criteria:
Inclusion Criteria:

* Indication for hind- or midfoot arthrodesis
* Informed Consent
* Body weight \< 90kg (according to Smartsens manufacturers recommendations)

Exclusion Criteria:

* Physical or mental inability to follow weight-bearing recommendations (e.g. dementia, neurologic disease, upper extremity pathology)
* Participation in a potentially interfering interventional trial during the last 30 day or before wash-out of any trial medication (e.g. steroids, medications affecting bone metabolism etc.)
* Previous infection at the intended surgical site
* Body weight \> 90kg
* Pregnancy
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.


Eligibility Criteria:
Inclusion Criteria:

Main criteria:

1. Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study.
2. Women between 30 and 80 years of age
3. Women having ≤5% of superficial cells on vaginal smear at baseline
4. Women having a vaginal pH above 5 at baseline
5. Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

Exclusion Criteria:

Main criteria:

1. Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
2. The administration of any investigational drug within 30 days of screening visit