cyrilzakka/clinical-trials huggingface dataset:
A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802

This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Male adults, 18 to 45 years of age, inclusive
* Body mass index (BMI) from 18 to 32 kg/m2, inclusive
* Willingness to 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 \& 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, HIV, alcohol, drugs of abuse, or tobacco
* Regular smoking within 6 months prior to first dosing. Subjects 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
* Regular work with ionizing radiation or radioactive material
* Subjects enrolled in a previous radiolabel study or who have received radiotherapy within 12 months prior to first dosing such that total radioactivity over a 12 month period would exceed an acceptable radiation burden \> 0.1 mSv
* Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton \[excluding spinal column\]), during work or participation in a medical trial in the previous year
* 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 60 days (or 6 months for biologic therapies) prior to first dosing
Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia

OBJECTIVES:

I. Evaluate the toxicity of amifostine in patients with bone marrow failure related to Fanconi's anemia.

II. Determine the efficacy of this treatment regimen in this patient population.

III. Evaluate the effect of this treatment regimen on bone marrow progenitor cell proliferation and peripheral blood mononuclear cell apoptosis in these patients.

PROTOCOL OUTLINE:

This is a dose escalation study.

Patients receive amifostine IV over 3-5 minutes three times a week for three weeks.

Cohorts of 3 patients receive one of three dose levels of amifostine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed weekly for 3 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of Fanconi's anemia by conventional diepoxybutane or mitomycin sensitivity assays, or molecular testing

Bone marrow failure verified on at least 3 occasions in the preceding 3 months by any one of the following: hemoglobin less than 8 g/dL; absolute neutrophil count less than 1,000/mm3; platelet count less than 30,000/mm3; symptomatic bone marrow failure (e.g., exercise limitation from anemia or spontaneous bleeding from thrombocytopenia)

Evidence consistent with myelodysplastic syndrome allowed if less than 5% blasts on bone marrow aspiration; clonality on bone marrow cytogenetic analysis OR morphological changes on bone marrow aspirate

Refusal of or unsuccessful with prior conventional therapies

--Prior/Concurrent Therapy--

Biologic therapy: No prior bone marrow transplantation; no concurrent hematopoietic growth factors

Endocrine therapy: No concurrent androgens

--Patient Characteristics--

Hepatic: Bilirubin no greater than 2 times normal AST no greater than 3 times normal ALT no greater than 6 times normal

Renal: Creatinine no greater than 2 times normal

Other: No prior malignancy; no active bacterial, viral, or fungal infection requiring therapy other than prophylaxis; not pregnant; negative pregnancy test
The Syn-Sleep Study

In collaboration with approximately 8 centers that specialize in iRBD we will recruit a total of 80 individuals for the study. All subjects will be enrolled into a 2-year longitudinal study where skin biopsies will be performed at 3 sites on each patient at 12-month intervals (baseline, year 1, year 2). Plasma blood collection will be performed at 12-month intervals (baseline, year 1, year 2). Detailed quantified examination, cognitive evaluation, medical history, and questionnaires will be performed at each visit. Additional biomarker, imaging and clinical information (if available) will be obtained for the purpose of determining phenoconversion to clinically apparent synucleinopathy.

Subjects enrolled in the study will have baseline evaluations and follow up visits at 12 and 24 months to define any changes to clinical diagnosis (clinical phenoconversion). Skin biopsies will be repeated at the 12- and 24-month follow up visits to determine the rate of P-SYN accumulation over time and the rates of nerve fiber degeneration within punch skin biopsies.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females age 18-85
2. Subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors
3. Sleep-related behaviors/disturbances must be documented by polysomnography to occur during REM sleep
4. Polysomnographic recording is consistent with REM sleep without atonia

Exclusion Criteria:

1. Subjects with MoCA \< 19, Hoehn and Yahr score \>/=1, contraindications to skin biopsy
2. Diagnosis of Parkinson's disease
3. Diagnosis of dementia of any type
4. Diagnosis of multiple system atrophy
5. REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease)
6. Contra-indications to skin biopsy:

   1. Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, and vascular claudication)
   2. History of allergic reaction to local anesthesia for skin biopsies
   3. Use of blood thinners (aspirin of Plavix alone is allowed)
   4. Significantly impaired wound healing or history of scarring or keloid formation
Auditory Training With Speech Related Acoustic Cues Using Psychophysical Testing

In this study, the investigators will evaluate whether auditory training with speech-related acoustic features in psychophysical testing will help CI subjects improve speech recognition. The primary endpoint is the speech recognition measures.


Eligibility Criteria:
Inclusion Criteria:

* Native speakers of English
* Cochlear Nucleus cochlear implant users or Advanced Bionics users
* Postlingually deafened
* Has had device experience for at least one year
* Can be child or adult at the time of enrollment

Exclusion Criteria:

* None
Single Portable Pulse-dose-conserving Device vs. Combined Use of Stationary and Portable.

Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was designed to compare oxygen saturation and patient satisfaction with a portable oxygen concentrator or with a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation.

Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4 years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously used the combined system, consisting of a fixed oxygenation system and a portable system for ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while walking were determined at baseline. Patients were maintained on the previous combined system for one week and then switched to the portable oxygen concentrator for one week. Mean SpO2 over 24 hours was calculated by the software in the oximeter, and compliance was monitored


Eligibility Criteria:
Inclusion Criteria:

* aged 40-80 years
* had been diagnosed with COPD following the GOLD criteria
* were receiving oxygen therapy using a fixed oxygenation system and a portable system for ambulation
* without exacerbation during the previous month
* agreed to participate

Exclusion Criteria:

* terminally ill
* unable to understand Spanish
* had high oxygen flow at rest (\> 3 lpm)
* high respiratory frequency at rest (\> 32 rpm)
* were not achieving adequate O2 saturation levels during titration with the portable oxygen source
* had previously been diagnosed with obstructive sleep apnea hypopnea syndrome (SAHS)
* were receiving mechanical ventilation.
Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation of the anterior globus pallidus. The best area within this brain region and the best stimulation device settings are currently unknown. This is a study in which deep versus superficial electrode contact positions and two different amplitudes of stimulation are compared under scientific conditions. The hypothesis is that one contact position/stimulation amplitude combination will provide a better outcome than the others. Each study participant receives each of four different anatomical position/stimulation amplitude setting combinations over a 12 month period in randomized order followed by a 6-month period of trial-and-error device programming to optimize control of motor tics. Motor tics, potential side effects, daily functioning and quality of life are assessed at the end of each trial stimulation period. At the end of the study, the study participant continues to have long-term deep brain stimulation treatment with whatever settings provide the most relief.


Eligibility Criteria:
Inclusion Criteria:

* Age 14 to 60 years
* Patient Group with Tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication

Exclusion Criteria:

* Surgical contraindications to deep brain stimulation surgery
* Major Depressive Episode within the previous 6 months
* Schizophrenia or other psychotic disorder
* Personality disorder impairing ability to reliably comply with study protocol
* Significant cognitive impairment
PDA Stent in Neonates With PDA Dependent Pulmonary Circulation

After echocardiography confirmation of PDA dependent pulmonary circulation in cyanotic neonates, catheter-guided PDA stent implantation will be done. Under general Anasthesia and after discontinuation of prostaglandin 4-6 hours before procedure, obtain vascular access and unfractionated heparin is given, then duct is accessed via a cut pig-tail or Judkins right \[JR\] catheter, and is crossed by PTCA wire to be carefully placed in the left or right branch pulmonary arteries, choose proper stent diameter and length, place the stent and confirm it's position, NICU admission for the neonate with heparin infusion for 24-48 hrs and acetylsalicylic acid is given then follow up the patient by pulse oximeter and echocardiography


Eligibility Criteria:
Inclusion Criteria:

Neonates and young infants with duct dependent pulmonary circulation

Exclusion Criteria:

* Untreated sepsis.
* Coagulopathy.
* PDA dependent systemic circulation.
The Impact of Mechanisms of Action in Unguided Digital Mental Health Interventions

This randomized controlled trial (RCT) will compare two interventions that utilize the same evidence-based components of established digital parent training programs (DPTs) aimed at treating child behavior problems, but that differ in terms of the quality of therapeutic persuasiveness (TP) quality (standard: DPT-STD; enhanced TP: DPT-TP). The investigators will recruit parents from 160 families with 3-7-year-old children with behavior problems who will be randomized into one of the two intervention arms. The investigators will measure child behavior problems and related parenting variables before, during, and after the intervention. DPT usage will be passively collected.

The investigators hypothesize that, compared to DPT-STD, parents allocated to the DPT-TP arm will have significantly better module completion rates (adherence to the program) and report better outcomes - measured by improvements in child behavior problems and related parenting variables. The investigators also hypothesize that changes in reported outcomes will be mediated by module completion rates. Therefore, comparing two active interventions that only differ in terms of their TP quality will enable to examine the causal link between this conceptual mechanism of action and beneficial outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Parents having a child between the ages of 3 and 7
* The parents report high levels of behavior problems demonstrated by their child based on the ECBI Intensity subscale (X ≥ 132)
* The parents have access to a smartphone device with an Internet connection.

Exclusion Criteria:

* The child is taking medication for behavioral or emotional problems
* The child is in regular contact with a professional for behavioral or emotional problems
* their child has been diagnosed with an intellectual disability or developmental delay
* The parents are currently accessing parenting support elsewhere
Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after previous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Genotype 1, chronic hepatitis C
* Relapsers (patient who relapsed after previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
The Treatment of Clavicular Fractures

Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.

Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 year
* 100% displaced midshaft clavicular fracture
* shortening

  * male: 18mm
  * female: 14mm

Exclusion Criteria:

* pregnancy
* pathological fracture
* open fracture
* history of frozen shoulder
* ipsilateral fracture of shoulder or scapula
* neurovascular injury
* contraindication to anaesthesia
Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms

Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. However, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to distinguish neoplastic from non-neoplastic during colonoscopy. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC can demonstrate the atypical of gland structure and cells after staining and display the super-amplified surface microvessels of the lesion under the EC-NBI mode. However, the judgment of endocytoscopic images needs a lot of experience to improve the diagnostic accuracy. Moreover, endoscopists have certain subjective judgments and errors in endocytoscopic diagnosis. There is an artificial intelligence system which has been developed to identify colorectal neoplasms. However, there is still a lack of prospective clinical verification based on Chinese population. In the study, the investigators performed a prospective clinical study to determine the diagnostic accuracy of artificial intelligence system.


Eligibility Criteria:
Inclusion Criteria:

* colorectal lesions

Exclusion Criteria:

* non-epithelial tumors
* a history of inflammatory bowel disease
* chemotherapy or radiation therapy for colorectal cancer
* lesions without clear EC images
* specific pathological types
* familial adenomatous polyposis
Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery

This study analyses interest of iv nefopam in combination with paracetamol after major abdominal surgery because the effect of morphine-sparing is discussed when combined these agents.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient with a score ASA between I and III
* Patient scheduled for elective major abdominal surgery (by laparotomy) for cancer or diverticulosis
* Patient that signed the consent form

Exclusion Criteria:

* - Patient treated in emergency situation
* Patient with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
* Patient that needs a surgery for restoration of continuity
* Patient pregnant, breastfeeding, or during periods of genital activity using no contraception.
* Patient with contraindications to nefopam, morphine, or paracetamol
* Patient with chronic obstructive pulmonary disease, renal or severe hepatic impairment
* Patient under analgesics treatment
* Patient who participated in a clinical study in the previous 6 months.
Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV)

The purposes of the present study are (1) to analyze baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors, and (3) to examine longitudinal clinical course in patients with chronic respiratory failure receiving domiciliary NPPV.

Limited data are available about the prognosis and its predictive factors in patients with chronic respiratory failure receiving domiciliary NPPV. In addition, their health status, psychological status and sleep quality seem to be highly disturbed due to severe respiratory insufficiency. Therefore, in the present study, we aim to examine (1) contributive factors to health status based on baseline data, (2) whether patient reported measurements such as health status, dyspnea and psychological status would predict patient's future outcomes, and (3) how they would change for 3 years as compared to physiological measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic respiratory failure receiving domiciliary NPPV for more than 3 months

Exclusion Criteria:

* Uncontrolled severe comorbidities
* Patients with tracheotomy.
Catgut Embedding in Acupoints on Treating Persistent Atrial Fibrillation After Catheter Ablation

This is a multi-center, 2-arm, assessor and statistician blinded, pilot randomized controlled trial, to evaluate the effect of catgut embedding in acupoints of Neiguan and Zusanli in reducing early recurrence and improving long-term prognosis in patients with persistent AF after CA..

This multi-center, 2-arm, assessor and statistician blinded, pilot randomized controlled trial will be conducted at two centers in China: Shanghai Chest Hospital; The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine. Patients with persistent atrial fibrillation after catheter ablation are 1:1 randomized into group A (amiodarone hydrochloride tablet + acupoint catgut embedding), group B (amiodarone hydrochloride tablet). ECG, inflammatory cytokines,AFEQT scale and other indicators are analyzed the effect of catgut embedding in acupoints of Neiguan and Zusanli in reducing early recurrence and improving long-term prognosis in patients with persistent AF after CA.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age between 18 and 80 years old; 2. Persistent AF（lasting no more than 3 years）after catheter ablation; 3. No acupuncture treatment within the previous 6 months.

Exclusion Criteria:

* 1. A history of allergy to acupuncture or amiodarone; 2. Severe heart failure (New York Heart Association（NYHA）class III or IV); 3. Echocardiographic parameters: left ventricular ejection fraction \< 40%, left atrium diameter \> 5.0cm; 4. Severe lung, liver, kidney disease or other serious primary diseases; 5. Skin allergy to ECG monitoring electrode patch. 6. The estimated life expectancy of \< 1 year.
Evaluation of Return to Work Rehabilitation

Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. Hence, the need for documented effective vocational rehabilitation programs is pressing. Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal-, unspecific- and common mental disorders. Aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW rehabilitation programs.


Eligibility Criteria:
Inclusion Criteria:

* living in the counties of Trøndelag
* on sick leave 2-12 months
* current sick leave status of 50% - 100%
* ICPC-2 (International Classification of Primary Care, Second edition) diagnosis within the L (musculoskeletal), P (psychiatric) or A (unspecific disorders) categories

Exclusion Criteria:

* alcohol or drug abuse
* serious somatic or psychological disorders
* a specific disorder requiring specialized treatment
* pregnancy
* currently participating in another treatment program
* insufficient Norwegian speaking or writing skills to participate in group session and fill out questionnaires
* scheduled for surgery within the next 6 months
* serious problems with functioning in a group setting