louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03622970: Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy
Official title: Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Rehabilitation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the effects of Neurodevelopmental Treatment (NDT)-based upper limb rehabilitation and video-game based therapy (VGBT) with Nintendo® Wii and LMC games on upper extremity functions in patients with Cerebral Palsy (CP).

Detailed description: The investigators hypothesized that VGBT using the Nintendo® Wii and LMC would be a usable tool to train manual dexterity in patients with CP as comprehensive and holistic therapy.

The NDT program for both groups will be routinely applied according to each child's individual needs and included tonus regulation, support of sensation, perception and motor development for gross motor function.

The two different patient-centered rehabilitation programs will be conducted with an average of one hour sessions three times a week for 8 weeks in both groups. The two different patient-centered programs will be as VGBT with Nintendo® Wii and LMC games (Group I) and NDT-based upper limb rehabilitation (Group II).

Eligibility criteria: Inclusion Criteria:

The health committee report has received a CP diagnosis

* Being between 5-18 years of age
* According to Modifiye Ashworth Scale (MAS), upper extremity spasticity (0), (1), (1+)
* Ability to adapt to exercises (According to the health report mental level normal or "mild mental retardation"

Exclusion Criteria:

* Botulinium Toxin (BOTOX) injection for the upper extremity in the last 6 months
* Does not have epileptic epilepsy
* Any person who has been diagnosed as having any absence of a cardiac or orthopedic condition
* Admission of family treatment

Primary outcomes:
measure: Minnesota Hand Dexterity Test
timeFrame: Change from baseline to 8 weeks, follow up at two months
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: Hand and pinch grips
timeFrame: Change from baseline to 8 weeks, follow up at two months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00857870: Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects
Official title: Comparative Investigation of Efficacy and Safety of Insulin Glargine Versus Metformin as First Line Drug in Treatment of Early Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
First posted: 2009-03-09
Enrollment: 96
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of efficacy and safety of glargine insulin and metformin as first line drug of patients insufficiently treated with lifestyle intervention. So far treatment also algorithm with lifestyle and metformin has not been evaluated in patients with type 2 diabetes and HbA1C greater or equal 7 % and lower than 8.1%.Besides HbA1C postprandial glucose excursion and glycemic variability as determinants of oxidative stress will be measured by continuous glucose measurement(CGM). Further more CGM will reveal risk of hypoglycemia at night. As secondary objectives effect on endothelial function, renal function and biomarkers of low great inflammation will be evaluated. So far only scarce information on face to face comparison in ealy diabetes exists.


Eligibility criteria: Inclusion Criteria:

* early type 2 diabetes (lower than 5 years known)
* male and female(35 to 75 years)
* HbA1c 7 to 8 %, if drug naive and \<= 8.5 with previous OAD intake
* Informed consent

Exclusion Criteria:

* any treatment more than one OAD at the same time
* treatment with one OAD \< 6 weeks time
* insulin treatment
* acute coronary syndrome \< 6 months
* severe liver disease
* alcohol abuse or drug addiction
* severe kidney disease
* acute critical illness with renal impairment
* i.v. application of iodine
* ketoacidosis
* acute or chronic illness witch may lead to hypoxia or cardial failure
* allergy against one of the drugs
* deficit in compliance or cooperation
* pregnancy or breast feeding
* women in fertile age without accepted contraceptive

Primary outcomes:
measure: Area under the curve (AUC) after a testmeal measured CGM.
timeFrame: baseline and visit 8
Secondary outcomes:
measure: HbA1C, glycemic variability, glycemic load, insulin secretion after testmeal, free fatty acids, biomarkers of low grade inflammation, endothelial dysfunction.
timeFrame: baseline and visit 8
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GWT -TUD, Center for Clinical Studies
Study officials:
References:
citation: Pistrosch F, Kohler C, Schaper F, Landgraf W, Forst T, Hanefeld M. Effects of insulin glargine versus metformin on glycemic variability, microvascular and beta-cell function in early type 2 diabetes. Acta Diabetol. 2013 Aug;50(4):587-95. doi: 10.1007/s00592-012-0451-9. Epub 2013 Feb 21.
Clinical trial NCT01771770: Measurement of Retinal Venous Pressure in Chronic Low-oxygen Environment
Official title: Measurement of the Retinal Venous Pressure (RVP) Under Conditions of Chronically Reduced Ambient Pressure and Oxygen Partial Pressure (Field Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: retinal venous pressure (RVP)
chronically reduced ambient pressure
oxygen partial pressure
mountain sickness
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: The hypothesis is that the pressure in the retinal veins increases from chronic lack of oxygen and leads to decreased blood flow. On the basis of high altitude mountaineering this hypothesis should be verified. At the same time the adaptation capacity of the blood circulation should be analyzed, and a relationship to mountain sickness should be found.

Detailed description: Conduct a field study to describe and quantify the retinal venous pressure (RVP) in healthy volunteers under conditions of controlled chronically reduced ambient pressure and oxygen partial pressure in the mountains. Obtaining indications regarding the adaptation of the retinal vascular system behavior to controlled, long-term hypoxic changes. Comparisons with blood pressure, pulse, oxygen saturation level and the appearance of symptoms of acute mountain sickness are made in order to obtain a better understanding of the development of high altitude illness.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* eye diseases
* systemic diseases
* term medication (except contraceptives)
* pregnancy
* allergies to the ingredients Alcain, Tropicamide and Phenylephrine

Primary outcomes:
measure: Quantify the changes in the retinal venous pressure (RVP).
timeFrame: 1-2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Dept. of Ophthalmology
Study officials:
affiliation: University of Basel, Dept. of Ophthalmology
name: Josef Flammer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01943370: Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement
Official title: Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Keywords: endoscopic sinus surgery
post-operative irrigation
pain
debridement
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 25
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic sinus surgery. However, the ideal timing and quantity of irrigation in the early post-operative period remains unknown. Proposed benefits of early, large volume irrigation include removal and softening of crusts, resulting in improved mucociliary clearance. The potential benefit of early large volume saline irrigation on post-operative day three to ease or reduce the need for early post-operative debridement has not been studied.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Diagnosis of CRS with or without polyposis
* Undergoing bilateral endoscopic sinus surgery
* Availability of pre-operative CT paranasal sinuses

Exclusion Criteria:

Patients with diagnosis of:

* Primary ciliary dyskinesia
* Immunodeficiency
* Cystic fibrosis

Primary outcomes:
measure: Pain
timeFrame: Early post-operative (Day 10)
Secondary outcomes:
measure: Endoscopic appearance
timeFrame: Early (post-operative day 10)
measure: Late endoscopic appearance at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00193570: Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors
Official title: A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory and/or Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Genentech, Inc.
First posted: 2005-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I study will characterize the safety, tolerability, and maximum tolerated dose and dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the combination regimen.

Detailed description: Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Upon determination of eligibility, patients will be receive:

* Docetaxel + Topotecan

In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of Topotecan and docetaxel will be utilized.

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Adult \> 18 years of age
* ECOG performance status 0 or 1
* Received 3 or less chemotherapy regimens in the metastatic setting
* Adequate bone marrow, liver and kidney function
* Prior brain metastases must be inactive and asymptomatic
* No previous treatment with Topotecan or docetaxel
* Understand the nature of the study and give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Moderate or severe peripheral neuropathy
* Active concurrent infection or serious underlying medical condition
* Known HIV positivity
* Pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Determine maximum tolerated dose of drug combination
Secondary outcomes:
measure: Response rates
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Howard A. Burris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04314570: Saphenous Nerve Block After Tibial Plateau ORIF
Official title: Saphenous Nerve Block for Post-Op Pain Control After Tibial Plateau ORIF
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tibial Plateau Fracture
Pain, Postoperative
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fractures of the tibial plateau, while very painful, typically do not receive nerve blocks. This is because of a concern that the numbness from a nerve block would "mask" the typically painful symptoms of compartment syndrome, a condition that can lead to a permanent loss of function of the injured limb. Our study aims to evaluate the effectiveness of saphenous nerve block for pain management after surgical repair of a tibial plateau fracture. Based on cadaver studies and our clinical experience, we suspect that the saphenous nerve contributes to pain sensations of the tibial plateau and will not mask the pain from a compartment syndrome. In summary, while saphenous nerve block represents a safe option after tibial plateau open reduction internal fixation (ORIF), we aim to evaluate its effectiveness in this patient population.


Eligibility criteria: Inclusion Criteria:

* Tibial plateau fracture presenting for ORIF
* Age greater than or equal to 18 years

Exclusion Criteria:

* Other concomitant life-threatening injuries
* History of chronic pain prior to tibial plateau ORIF
* Age \<18 years old
* Pregnancy
* Any condition impairing patient's ability to consent to participation in study
* Existing condition contraindicating a nerve block
* Non-English Speaking

Primary outcomes:
measure: Pain Scores
timeFrame: Through hospital stay, an average of 3 days
measure: Opioid requirements
timeFrame: Through hospital stay, an average of 3 days
measure: Length of Stay
timeFrame: Through hospital stay, an average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02055170: Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
Official title: Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: CancerCare Manitoba
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control.

In this study, the protein where testosterone binds, called the androgen receptor (AR), will be measured in samples from the patient's biopsy and surgical tumor samples. The investigators will look at a marker of how fast the cancer is growing (Ki67) before using finasteride from your biopsy specimen. Finasteride will be taken from the day of consent until the day of the patient's surgery. This marker will be measured again after using finasteride from the surgical specimen. The investigators will be looking for a decrease in the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that this medication is blocking tumour growth.


Eligibility criteria: Inclusion Criteria:

* male
* age \>18
* biopsy-proven non-small cell lung cancer
* surgical intervention planned

Exclusion Criteria:

* current use of 5-alpha reductase inhibitor
* previous diagnosis of prostate cancer
* previous hypersensitivity to 5-alpha reductase inhibitor

Primary outcomes:
measure: Change in proliferation
timeFrame: Original biopsy to surgical specimen (approx 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
References:
Clinical trial NCT01350570: Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial
Official title: Acupuncture for Functional Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Functional Diarrhea
Keywords: acupuncture
loperamide
functional diarrhea
IBS
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
First posted: 2011-05-10
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.

Detailed description: Outcome measurements:

The frequency of bowel movement; The bristol stool scale; SF-36 evaluation

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;
2. Age between 18 and 65 years old;
3. Did not take any medicine for bowel symptoms and attend other clinical research;
4. Have inform consent signed.

Exclusion Criteria:

1. Diarrhea caused by diseases such as infection, etc.
2. Patients can't express himself clearly or with mental diseases;
3. Tumor and other infectious diseases;
4. With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.

Primary outcomes:
measure: Average weekly stool frequency
timeFrame: 4th week after inclusion
Secondary outcomes:
measure: Assessment score of Bristol stool scale
timeFrame: 4th and 8th week after inclusion
measure: Assessment score of SF-36 scale
timeFrame: 4th and 8th after inclusion
measure: Number of patients with adverse events after treatment
timeFrame: 4th week after inclusion
Other outcomes:
Locations:
city: Chengdu
country: China
facility: First affiliated hospital of Chengdu university of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of TCM
name: Ying Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02950870: Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.
Official title: An Open-Label Study to Evaluate Long-Term Outcomes With Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Fertile Women With Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis, C Virus
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment.

Detailed description: The study is interventional, controlled randomized (block 2:1 case: controls) in open label.

Eligibility criteria: Inclusion Criteria:

* Female between 18 and 35 years of age at the time of Screening
* Childbearing potential and sexually active with male partner(s) currently using at least one effective method of birth control at the time of screening and two effective methods of birth control while receiving study drugs, starting with Study Day 1 and for 7 months after stopping study drug.
* Females must have negative results for pregnancy tests
* Chronic HCV-infection prior to study enrollment
* Screening laboratory result indicating HCV GT 1b or GT 1a or GT 4 infection.
* Must be able to voluntarily sign and date an informed consent form
* Liver biopsy within 24 months prior to or during screening demonstrating a Metavir score of 2 or less or an Ishak score of 3 or less or Screening FibroScan® result of ≤ 9.6 kPa;

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Positive test result for HBsAg and HIV Ab
* Recent history of drug or alcohol
* HCV genotype performed during screening indicates more than 1 subtype or co-infection with any other genotype.
* Use of medications contraindicated
* Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8
* History of solid organ transplant.
* Confirmed presence of hepatocellular carcinoma
* Current use of any investigational or commercially available anti-HCV agents
* Screening laboratory analyses showing any of the following abnormal laboratory results

Primary outcomes:
measure: The modification of AMH levels
timeFrame: 48 weeks post treatment
Secondary outcomes:
measure: Modification of AMH levels
timeFrame: 144 weeks
measure: Modification of the Estradiol (E2) levels
timeFrame: 144 weeks
measure: Percentage of participants experiencing miscarriage
timeFrame: 144 weeks
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Gastroenterology Unit
Study officials:
affiliation: Gastroenterology Unit
name: ERICA VILLA, Prof.
role: PRINCIPAL_INVESTIGATOR
References: