cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers

This open-label study will investigate whether multiple oral doses of posaconazole affect the single dose pharmacokinetics of alectinib in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 to 32 kilogram per square meter (kg/m\^2)
* Male volunteers must use effective contraception as outlined in the protocol
* Willingness to abstain from alcohol and xanthine-containing beverages or food (coffee, tea, cola, chocolate and "energy drinks") from 72 hours prior to the first dose until discharged
* Willingness to avoid prolonged sun exposure and guard against sunburn during study and follow-up

Exclusion Criteria:

* Clinically significant medical history or findings in physical examination, vital signs, or laboratory test results prior to study start
* Positive screening tests for hepatitis B or C, human immunodeficiency virus (HIV), alcohol, drugs of abuse, or tobacco
* Women of childbearing potential, or males with pregnant or lactating partners
* Regular smoking within 6 months prior to first dosing. Participants should avoid smoky environments for at least 1 week prior to each cotinine screen
* Excessive alcohol consumption
* Use of any metabolic inducers (including herbals such as St. John's Wort) within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study medication, including but not limited to: rifampin, rifabutin, glucocorticoids, carbamazepine, phenytoin and phenobarbital
* Strenuous activity, sunbathing, or contact sports are not allowed from 4 days prior to entry into the clinical site until study follow-up
* Participation in an investigational drug or device study within 45 days (or 6 months for biologic therapies) prior to first dosing
Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease

Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. At each follow-up visits, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.

This prospective, double-blind, randomised, placebo-controlled study aims to evaluate efficacy and safety of fecal microbiota transplantation for constipation in Parkinson's disease. Participants will be given either FMT capsules or placebo capsules at a ratio of 1:1. For experimental group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. After 24-week treatment, participants complete specific scales to assess improvement in constipation, other PD symptoms, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who fulfill Chinese diagnostic criteria for PD (2016 edition), aged 40-75 years;
2. PD Hoehn-Yahr stage 1-3
3. Participants who have at least 2 of the following symptoms in the past 3 months and the symptoms have been present for at least 6 months: ① More than 25% of defecations are laborious; ② More than 25% of defecations consist of hard or lumpy stools; ③ More than 25% of defecations are accompanied by a sensation of incomplete evacuation; ④ More than 25% of defecations are accompanied by a sensation of anorectal obstruction; ⑤ More than 25% of defecations require manual assistance; ⑥ Less than 3 spontaneous bowel movements per week.
4. Have taken a stable dose of anti-Parkinson drugs, antidepressants and antipsychotics for at least 1 month;
5. Absence of red flags such as weight loss, hematochezia and exclusion of other diagnosis;
6. Have signed the informed consent and agree to participate in this study;

Exclusion Criteria:

1. Parkinsonism-plus syndrome;
2. Stroke, brain trauma or epilepsy;
3. Have undergone surgery intervention due to PD;
4. Pregnant, planning pregnancy or lactating;
5. Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
6. Immunodeficiency or treatment with immune-modulating medication;
7. Have undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
8. Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
9. Use of probiotics or antibiotics within 1 month prior to study entry;
10. Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
Nebulizer Delivery of Intranasal Scopolamine

To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.

An aqueous scopolamine formulation is being administered via a nebulizer and the pharmacokinetics of the drug are being measured.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Adults age 21-49
* Normal weight for body size, based on BMI table
* General good health, as determined by a verbally provided medical history
* Normal brief neurological exam
* Renal and hepatic function within normal ranges
* Able to provide written informed consent to participate

Exclusion Criteria:

* Drug allergies to scopolamine or other belladonna alkaloid
* Use of medications within 1 week of starting the study
* Use of an investigational drug within 30 days of starting the study
* Tobacco smoking within the past year
* Blood donation or significant blood loss within 30 days of starting the study
* Significant gastrointestinal disorder (e.g. Crohn's Disease, ulcerative colitis, chronic constipation), asthma, glaucoma, prostate problems, urinary obstruction, or seizure disorders
* History of alcohol or other drug abuse
* Pregnancy or suspected pregnancy, or lactation (pregnancy will be confirmed with urine pregnancy testing prior to drug administration)
* Consumption of grapefruit juice within 7 days of scopolamine (SCOP) administration
* Nasal, nasal sinus, or nasal mucosa surgery within 90 days prior to study initiation
* Other significant surgeries within 90 days
* Significant deviated septum that blocks air flow in one nostril
* Rhinitis, sinus infection, severe allergies, and other upper respiratory infections within 30 days prior to the study
* Current use of an intranasal medication
* Wheezing or other respiratory problem
* Unable to consent
* Prisoner
Targeted Lung Denervation for Patients With Moderate to Severe COPD

The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.

A prospective, sequential two phase multicenter, randomized double-blind, safety, \& feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the optimal energy dose to a sham control. All subjects will be followed for a minimum of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD with 30% ≤ FEV1 \< 60% and FEV1/FVC \<70% (post-bronchodilator);
* Patient ≥ 40 and ≤ 75 years of age at the time of consent;
* The patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable;
* Smoking history of at least 10 pack years;
* Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study;
* Participated in a pulmonary rehabilitation program or engaged in regular physical activity under professional supervision in the past 12 months;

Exclusion Criteria:

* Has been less than 6 weeks following the resolution of a COPD exacerbation or active lower respiratory infection (eg. pneumonia);
* History of recurrent respiratory infections and/or COPD exacerbations (more than 2 hospitalizations within 1 year of enrollment);
* Prior lung or chest procedure (eg. lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy);
* Documented history of asthma diagnosed with onset \<30 years of age, cystic fibrosis, paradoxical vocal cord motion, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis;
* Pulmonary nodule requiring follow-up or intervention unless proven benign;
* Daily use of \>10 mg of prednisone or its equivalent at the time of enrollment;
Epidemiology of Patients Consulting for Original LBP Spinal Adult Emergency

Lumbar pain is an extremely common complaint in general population. The direct and indirect costs incurred in are a real public health problem.

Cohort studies show that improving symptoms after consultation for lumbar pain is insufficient, but there are few data on emergency medical and surgical services in France. In order to reflect on areas for improvement the investigators to carry out an inventory of consultations for lumbar pain emergencies of Hautepierre Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to adult emergencies in Hautepierre for lumbago pain, with or without sciatica,
* Age greater than or equal to 18 years
* Having signed non-opposition to participation in the study
* Having completed the initial questionnaire

Exclusion criteria:

* Spinal trauma in the month before the consultation
* Pain of non-spinal origin (pyelonephritis, colic Nephritic, aortic dissection ...)
* Non-Francophone Patients
* Patient under tutorship or under curatorship
* Patient under safeguard of justice
Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C

Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.

The objective of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin or Glecaprevir / Pibrentasvir (referred to as Mavyret) for adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. During the course of this prospective, single arm treatment trial, we will measure currently accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with eradication of HCV.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 year of age
2. HCV genotype 1 ≥ 1000 IU/mL
3. 6. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation

Exclusion Criteria:

1. Pregnant or lactating females
2. Uncontrolled depression or psychiatric disease
3. History or presence of any form of cancer within 3 years of enrollment
4. Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.
5. Uncontrolled cardiovascular or pulmonary disease
6. Experiencing symptoms attributed to uremia
7. Anticipated need to begin renal replacement therapy in the next 6 months
8. History of kidney transplant
Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs

To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection

Hepatitis C has been associated with substantial resource utilization as a result of its effect on the liver as well as other organ systems (the extrahepatic manifestations of HCV). It has been widely reported to have a profound negative impact on patient's health-related quality of life (HRQL).

The reduction of HRQL is probably also due to physical and psychiatric symptoms as a direct consequence of this chronic infection and its sequelae (such as cirrhosis). The chronic inflammation is believed to signal the brain and to give rise to neurovegetative symptoms (e.g. malaise and fatigue) and to amongst others depression and concentration difficulties. Possibly, also the brain itself is infected by HCV . The Egyptian government introduced Sofosbuvir as the first DAAs into Egypt through the government funded National Treatment Program. These agents are highly efficacious with significantly fewer side effects .

To date, there is only one study reported about how Egyptian HCV patients receiving the new DAAs perceive their HRQL. This study is first one to be done in Upper Egypt to assess health-related quality of life of HCV patients receiving direct acting antivirals (DAAs) therapy prior and at the end of therapy

Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatitis C related liver cirrhosis (diagnosed clinically laboratory and by imaging).
* Age 18 years or older
* Eligible for starting DAAs therapy according to Egyptian National Guidelines will be enrolled.
* Follow up of those patients during and after DAAs therapy (clinically ,laboratory,imaging and with a questionnaire ) to determine HRQL.

Exclusion Criteria:

* Any patient with liver cirrhosis secondary to causes other than chronic HCV infection e. g. auto immune liver disease, PBC
* Coinfection with other viruses as HBV, HIV.
* Had significant psychiatric illnesses (diagnosed by psychiatrist)
Ultrasound-assisted Versus Real-time Ultrasound-guided Combined Spinal-epidural Anesthesia in Elderly Patients

This study aims to compare the clinical effects of ultrasound-assisted localization and real-time ultrasound-guided combined spinal-epidural anesthesia via paramedian approach in elderly patients

This study aims to compare the clinical effects of ultrasound-assisted localization and real-time ultrasound-guided combined spinal-epidural anesthesia via paramedian approach in elderly patients

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (≥ 60 years old);
* ASA Grade I to III.

Exclusion Criteria:

* Severe obesity (BMI\>35kg/m2);
* Spinal deformity or surgical history;
* Allergic to local anesthetics;
* There are coagulation disorders;
* Communication barriers
ClarVista HARMONI Toric Trial With Intraoperative Exchange

The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.

Subjects were implanted with the HARMONI® Modular Intraocular Lens System (HMIOL). The eye with the higher corneal astigmatism (study eye) was assigned to Cohort 1 and received the HARMONI® Modular Intraocular Lens System with a toric optic. The fellow eye was assigned to Cohort 2 and received the HARMONI® Modular Intraocular Lens System with a non-toric optic during primary implantation, which was replaced with the appropriate optic power (toric or non-toric) during an intraoperative exchange (IOE) procedure. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, which included a Day -90 to Day -0 preoperative period.

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

Eligibility Criteria:
Key Inclusion Criteria

* Willing and able to return for scheduled treatment and follow-up examinations for up to 6 month study duration.
* Planned removal of visually significant bilateral cataracts.
* Pre-existing corneal astigmatism in at least 1 eye.
* Willing to discontinue contact lens wear for the duration of the study.
* Best Corrected Visual Acuity (BCVA) projected to be 0.2 logarithm Minimum Angle of Resolution (logMAR) or lower.
* Visual symptoms related to cataracts.

Key Exclusion Criteria

* History of any intraocular or corneal surgery in either eye (including refractive).
* Pregnant or lactating.
* History of any clinically significant retinal pathology or ocular diagnosis in either eye that could alter or limit final postoperative visual prognosis.
* History of any ocular condition which could affect the stability of the intraocular lens (IOL) in either eye.
* Uncontrolled glaucoma in either eye (per Investigator judgement).
* Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements
Monitoring Everyday Life Motor Activity in Children

The overall aim of this project is to monitor everyday life activity of children with neurological disorders undergoing rehabilitation using wearable sensors capable of accurate and unobtrusive long-term measurement.

Specific objectives:

1. To adapt the sensors for the use by children with neurological disorders. The focus lies on the exact positioning and the investigation of the needed amount of IMUs.
2. To validate the sensor data with collected video recordings and to develop specific algorithms to automatically extract specific movements and to analyze long-term sensor recordings.
3. To perform a cross-sectional study to assess intensity, task-specificity and duration of upper and lower limb activity during rehabilitation. There, we aim to gain objective information about levels and types of activity during rehabilitation in relation to age, gender and disorder.
4. To conduct a responsiveness study to assess whether or not the sensor output is able to highlight changes over time during rehabilitation.

Therefore, at time point T=0 (shortly after admission to our center), participants are equipped with 3 inertial measurement units (1 at each wrist and 1 at the sternum). Additionally, a small wearable camera is mounted to the chest. The participants then return to their everyday life for 4 hours (no therapies, measurement period is in the evening). Afterwards, the equipment is removed again. To investigate responsiveness, the same protocol is being repeated 4 weeks later (time point T=1).


Eligibility Criteria:
Inclusion Criteria:

* Various neuro-orthopedic diagnoses. Broad inclusion criteria are required to better generalize study results to the patient population of our center.
* Both walking or in wheelchair, but mobility independent from assisting people
* Cognitive ability to be able to follow simple verbal instructions.
* Signed informed consent from legal guardians and also from adolescents aged 15 years or older before study onset.
Preoperative Gabapentine for Carpal Tunnel

The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

There was studied 40 patients. Group 1 patients received 600 mg of gabapentin 1 hour before surgery; G2 received placebo 1 hour before surgery.

Anesthesia was regional intravenous block. Postoperative analgesia when needed was with acetaminophen. If needed was administered codeine. The evaluation of neuropathic pain was made by DN4 questionnaire. Pain intensity was assessed by numeric scale at block and after 30min, 1h, 2h, 2wk, 4wk, 6m. It was noted the duration of analgesia, and the amount of acetaminophen and codeine.

The statistical program used for analysis of the results was the Instat Graph

Eligibility Criteria:
Inclusion Criteria:

* carpal tunnel syndrome

Exclusion Criteria:

* disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant
Use of Motivational Interviewing to Increase Contraception Use Among Young Women

Study design: This is a 2-phase study. During the first phase, the investigators developed a contraceptive counseling intervention based on the principles of Motivational Interviewing, trained counselors, and conducted a small pilot study to develop skills and refine the intervention.

The second phase is this feasibility randomized controlled trial (RCT) to compare outcomes between:

Group 1 - Women randomized to a 20-40 minute contraceptive counseling session based on the principles of motivational interviewing, vs.

Group 2 - Women receiving usual clinic care.

Population: Women, aged 15-29 years, presenting to the University of Chicago family planning clinic for termination of an unintended pregnancy.

Hypothesis: A larger proportion of women who are randomized to receive the MI counseling intervention will be using very effective contraception 3 months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 15-29 years
2. Presenting for elective termination of an unintended pregnancy
3. Has not had contraceptive counseling from the team.
4. Willing and able to understand and comply with study protocol
5. Willing and able to sign an informed consent in English

Exclusion Criteria:

1. Current pregnancy intended
2. Current pregnancy desired
3. Reason for pregnancy termination not elective (e.g. fetal anomalies, pregnancy resulted from rape or incest)
4. Plans pregnancy within 6 months
5. Has been administered any sedatives or cervical ripening agents
6. For minors, must not be a ward of the state.
A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity

The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.


Eligibility Criteria:
Key inclusion criteria

* Male or female.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* BMI between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Key exclusion criteria

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening.
* Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

  1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening
  2. Parathyroid hormone (PTH) outside normal range at screening
  3. Total calcium outside normal range at screening