louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04066400: Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
Official title: Role of a Wheat-based Diet in NASH (NASH-ATI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NASH - Nonalcoholic Steatohepatitis
Diabetes Mellitus, Type 2
Hyperlipidemias
Keywords: hepatic inflammation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Goethe University
First posted: 2019-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, controlled, bicentric pilot study
Primary purpose: TREATMENT

Brief summary: Effects of Wheat-based diet vs. ATI-free diet on NASH

Detailed description: 40 patients with the diagnosis of a non-alcoholic- steatohepatitis (NASH) will be recruited at the University Hospitals of Mainz and Frankfurt. Patients are assessed with regards to their diet using standardized questionnaire and nutritionists.

Patients will be randomized into two parallel groups. The first group will continue a wheat-based Nutrition, while the second Group will receive dietary counselling to achieve an ATI-free nutrition, trying to reduce the daily ATI consumption.

The clinical trial will run over 16 weeks including 4 visits at the study center. Study visits include physical examinations, blood-based parameters, cytokines and urine samples, as well for the analysis of the intestinal microbiome by using stool samples. In addition the patients have to complete dietary and health-related quality of life (HRQL) questionnaires. Visits are planned at baseline, W4, W8 and W16.

Eligibility criteria: Inclusion Criteria:

* histologically proven NASH in the past 36 months with increased ALT: males: \>60, females: \>42 U/ml
* no body weight modification about \>10% in the past 24 weeks
* no new drugs treating parts of the metabolic syndrome in the past 12 weeks
* for patients with Diabetes: HbA1c value \<8,6%
* the ability to understand the aim and the possible individual consequences of this Trial
* signed and dated consent before the Trial starts

Exclusion Criteria:

* unstable coronary heart disease, stroke in the past 6 months
* different liver diseases
* proceeded fibrosis (Fibroscan \>9,6 kPA) or histological cirrhosis
* hepatocellular carcinoma or not curative treated carcinomas
* alcohol consumption \>10g/day (females), \>20g/day (males)
* gravidity
* drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids)
* immunological or inflammatory diseases (e.g. systemic Lupus erythematodes)
* warfarin therapy
* implementation of another Special diet

Primary outcomes:
measure: Effect of ATI-free Nutrition on hepatic inflammation
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of Life using the chronic liver disease questionnaire (CLDQ)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Universität Frankfurt
city: Mainz
country: Germany
facility: University Medical Center Mainz
Study officials:
References:
Clinical trial NCT02094300: Zenith® Dissection Endovascular System
Official title: Zenith® Dissection Endovascular System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Dissection
Keywords: Aorta
Thoracic
Aortic dissection
Rupture
Type B
DeBakey type III
Endovascular
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 26
Sex: ALL
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 Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of patients with aortic dissection.


Eligibility criteria: Inclusion Criteria:

* Branch vessel obstruction/compromise
* Peri-aortic effusion/hematoma
* Resistant hypertension
* Persistent pain/symptoms
* Transaortic growth \>5 mm within 3 months
* Transaortic diameter \>40 mm.

Exclusion Criteria:

* Age \<18 years;
* Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
* Pregnant, breast-feeding, or planning on becoming pregnant within 24 months;
* Unwilling or unable to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
* Additional medical restrictions as specified in the Clinical Investigation Plan, or
* Additional anatomical restrictions as specified in the Clinical Investigation Plan.

Primary outcomes:
measure: Number of Patients With Major Complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Boston,
country: United States
facility: Massachusetss General Hospital
state: Massachusetts
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadephia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: The Cooper Health System
name: Joseph Lombardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.
Clinical trial NCT06550700: The Outcomes of Laparoscopic Hybrid Surgery Versus Totally Open Surgery
Official title: The Outcomes of Simultaneous Resection for Colorectal Cancer Liver Metastases by Laparoscopic Hybrid Surgery Versus Totally Open Surgery: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resectable Simultaneous Colorectal Cancer Liver Metastasis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 266
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study collected clinical data from patients who underwent simultaneous resection of colorectal cancer liver metastases at the Department of Colorectal Surgery in Changhai Hospital from January 2010 to June 2021.

Brief summary: Simultaneous colorectal cancer liver metastasis (SCRLM) is one of the risk factors for poor prognosis in colorectal cancer. Surgical resection of primary and metastatic lesions is the first choice of treatment for patients with resectable SCRLM. Simultaneous resection of colorectal cancer liver metastases by totally open surgery (TOS) has been widely used. However, we propose that laparoscopic hybrid surgery (LHS) may have better short and long-term outcomes. This study aimed to compare the safety, short-term, and long-term efficacy of LHS versus TOS for patients with resectable SCRLMs.


Eligibility criteria: Inclusion Criteria:

* Liver metastasis was detected while the colorectal cancer was diagnosed.
* Both the primary lesions and liver metastases were confirmed by postoperative pathological examination.
* Clinical data is complete.

Exclusion Criteria:

* Patients with unresectable extrahepatic metastases.
* Patients with other malignant tumor diseases that have not been cured.
* Clinical and pathological data were missed or incomplete follow-up data.

Primary outcomes:
measure: short-term outcome: Operative time
timeFrame: Within one week of the patient undergoing surgery
measure: short-term outcome: Blood loss
timeFrame: Within one week of the patient undergoing surgery
measure: short-term outcome: Time of liquid diet
timeFrame: Within one week of the patient undergoing surgery
measure: short-term outcome: Postoperative hospital stay
timeFrame: Within one week of the patient undergoing surgery
measure: short-term outcome: Surgical complications
timeFrame: Within one week of the patient undergoing surgery
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 3years
measure: disease-free survival (DFS)
timeFrame: 3years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Colorectal Surgery in Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00249600: Lower-Cost Contingency Management in a Group Setting - 1
Official title: Lower-Cost Contingency Management in a Group Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: contingency management
substance abuse
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-07
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in enhancing attendance, reducing drug use, and improving health among clients attending two HIV drop-in centers. Specifically, 172 clients are randomly assigned to one of two 6-month treatment conditions: standard 12-step oriented group treatment, or CM group treatment. In the CM group, clients earn the chance to win prizes for submitting clean urine specimens and for complying with steps toward their treatment goals. Activities related to improving health will be emphasized, such as attending medical appointments, recording daily medication consumption, getting prescriptions filled, and attending medication adherence support groups. Group attendance, drug use, medical problems, services received, and risky drug use and sexual behaviors will be measured pre-treatment and at months 1, 3, 6, 9 and 12.


Eligibility criteria: Inclusion criteria:

* HIV-positive and a member of The Living Center or the Manchester Area Network on AIDS
* DSM-IV diagnosis of current opioid or cocaine abuse or dependence
* willingness to accept random assignment to one of the two treatment groups

Exclusion criteria:

* inability to comprehend the study (Mini-mental status score \<21; Folstein \& Folstein, 1975; or inability to pass an informed consent quiz)
* severely disruptive behavior
* in recovery for pathological gambling (due to potential similarity between the CM procedure and gambling)
* non-English speaking

Primary outcomes:
measure: Drug use
timeFrame: baseline and each follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05658900: Volumetric Analysis of Bone Following Jaw Cysts Enucleation With and Without Alb-PRF
Official title: Three-dimensional Volumetric Analysis of Bone Regeneration Following Jaw Cysts Enucleation With and Without Autologous Albumin Gel-platelet-rich Fibrin Mixture (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Jaw Cysts
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 20
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: Cyst is the main cause for longstanding swelling in the mandible or the maxilla, its enlargement usually results in resorption and weakening of bone. Thus the treatment of the cysts is essential to preserve the bone and the adjacent vital structures. Healing of the bone defect and its surrounding soft tissues is a critical issue that needs concerns. Although the Platelet rich fibrin has promising effects in wound healing, it can resorb during 10-14 days. Thus a new autologous platelet concentrate is introduced by Kawasi et al that can remain stable for 4-6 months called albumin PRF.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from jaw cystic cavity volume greater than 1cm3
* Patients with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 6 months.
* Cystic lesion that requires removal under local or general anaesthesia.

Exclusion Criteria:

* Medically compromised patients contradicting operation.
* Patients with history of chemotherapy or radiotherapy.
* Patients with low level of platelet count.
* Patients with anticoagulant therapy.
* Patients who are unable to attend follow up appointments

Primary outcomes:
measure: Change in pain score
timeFrame: Up to 1 week
measure: Change in soft tissue healing
timeFrame: up to 2 weeks
measure: change in bone volume
timeFrame: at baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT06721000: Patient Control Epidural Versus Conventional Epidural.
Official title: Patient Control Epidural Versus Conventional Epidural After Total Hip Replacement
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Post Operative Pain, Acute
Sedation Score
Degree of Motor Block
Length of Hospital Stay
Amount of Analgesic Used
Keywords: Patient control epidural analgesia
Conventional epidural
Lead sponsor: Liaquat National Hospital & Medical College
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient population will be from liaquat national hospital.

Brief summary: As one of the complications of THR is post operative pain, which usually requires epidural catheter insertion.

We are comparing the effect of patient control epidural versus conventional epidural for patient's satisfaction.

Detailed description: More than 20 years of successful usage of epidural analgesia for post operative pain treatment include intermittent provider-administer bolus, patient control analgesia and continuous epidural infusion with or without patient control epidural analgesia. The main drawback of conventional epidural infusion is that it does not allow for individual variation in management of pain. As a result, patient control epidural analgesia has replaced it in recent years.3. It has been demonstrated that continuous epidural infusion with patient control epidural analgesia is highly effective at providing consistent analgesia, improving patient satisfaction, and reducing the workload of anesthesia provider but it is linked to higher local anesthetic consumption4 In patient undergoing THR, patient control epidural analgesia may be considered as an appropriate alternative for managing post operative pain.

Eligibility criteria: Inclusion Criteria:

Age \>18 years. ASA 1-2 on pre anesthesia evaluation. Spontaneous breathing. Spo2 \>95% Informed consent for participation.

Exclusion Criteria:

A history of long-term opioid therapy (use of opioid analgesic at doses higher than codeine 120mg/day, hydrocodone 40mg/day, tramadol 200mg/day or oxycodone 40mg/day 0-4 days before surgery).

Indication of revision surgery during immediate post operative care. Acute skin disease. Patients' refusal. ASA 3 and 4. Hypersensitivity to study drugs.

Primary outcomes:
measure: Visual analogue score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Liaquat national hospital and medical college
state: Sindh
Study officials:
References:
Clinical trial NCT06234800: Observational Study on Implant Removal
Official title: Reasons for Implant Failure and Removal: A Retrospective Study in a Hospital Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Complication
Lead sponsor: George Eastman Dental Hospital, Italy
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presenting to the department of Oral Surgery with failing or failed osteointegrated dental implants.

Brief summary: Reporting of the reason for implant removal in a hospital setting over 20 years. retrospective design.


Eligibility criteria: Inclusion Criteria:

* all rehabilitated dental implants

Exclusion Criteria:

* implants with complications that were treated and didn't require removal for complication management.
* patients who could not undergo implant removal for reasons of general health

Primary outcomes:
measure: Implant survival
timeFrame: from 2000 to 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: George Eastman Dental Hospital
Study officials:
References:
Clinical trial NCT02779400: Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement
Official title: Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Heart Valves
Arrhythmias, Cardiac
Thromboembolism
Keywords: INR
coagulation
vitamin K antagonist
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).

Detailed description: The investigators will assess the performance of an in vitro diagnostic device for assessing the INR.

The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.

The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.

A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* Patients treated with vitamin K agonist or healthy volunteers
* For healthy volunteers : Body Mass index between 18 ans 29 kg/m²
* No acute disease in the previous month

Exclusion Criteria:

* Pregnant woman

Primary outcomes:
measure: Accuracy of measurement of the INR with the study device
timeFrame: Just after the blood taken at day 1
Secondary outcomes:
measure: Repeatability of measurement of the INR with the study device
timeFrame: Just after the blood taken at day 1
measure: Reproductibility of measurement of the INR with the study device
timeFrame: Just after the blood taken at day 1
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical research center of Grenoble university hospital
state: Rhône Alpes
Study officials:
References:
Clinical trial NCT01556100: Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
Official title: Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: 18F-DTBZ AV-133 imaging
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

Detailed description: The primary objective of this protocol is to assess the rate of change in striatal 18F-DTBZ uptake in a cohort of Parkinson's disease patients.

This study is expected to be completed in a period of 4 years.

Eligibility criteria: Inclusion Criteria:

1. Male or female age 20 years to 80 years.
2. Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible" or "probable" PD1.
3. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent)

Exclusion criteria:

1. Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
2. Alcohol or substance abuse.
3. History or presence of QTc prolongation. (\>500msec)
4. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
5. Unable to stay still in the MRI or PET scanner for 30 minutes.
6. Pregnancy and breast feeding.
7. Hepatic dysfunction with liver function test (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) of \> 3x the upper limit of normal

Primary outcomes:
measure: Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36
timeFrame: three years
Secondary outcomes:
measure: To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients.
timeFrame: three years
Other outcomes:
Locations:
Study officials:
References: