louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03685396: Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage
Official title: Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage: a Comparative Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Postoperative Complications
Gingival Recession
Keywords: Connective tissue graft
Platelet concentrates
PRF
Mucogingival surgery
Lead sponsor: Azienda Ospedaliera San Paolo
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates postoperative morbidity of patients that undergo free gingival graft harvesting from palate with or without use of autogenous PRF (Platelet Rich Fibrin) membranes to cover the donor site.In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site, whereas in Control Group hemostatic agents with oxidized and regenerated cellulosa were used.


Eligibility criteria: Inclusion Criteria:

* FMPS (Full Mouth Plaque Score) and FMBS (Full Mouth Bleeding Score) \< 20%,
* presence of two adjacent Miller's Class I and II recession defects on natural teeth (≥ 2mm in depth);

Exclusion Criteria:

* contraindications for periodontal surgery
* taking medications or having diseases known to interfere with periodontal tissue health or healing and coagulation.
* smoking more than 10 cigarettes a day
* Gingival recessions on molar teeth were excluded.

Primary outcomes:
measure: Post-operative Pain: VAS
timeFrame: 2 weeks.
measure: Post-operative Discomfort
timeFrame: 2 weeks
measure: Post-operative Stress
timeFrame: 2 weeks
measure: Post-operative Inability to Chew
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Azienda Ospedaliera San Paolo - Polo Universitario - Università degli Studi di Milano
state: Milano
Study officials:
References:
Clinical trial NCT00905996: Primary Prophylaxis of Gastric Varix Bleed
Official title: A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2009-05-21
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. The investigators conducted a randomized controlled trial in patients with gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.

Detailed description: Patients are followed up every 3 months or at the time of end point or complications.

Eligibility criteria: Inclusion Criteria:

* Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.

Exclusion Criteria:

* Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection.
* Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from GV
* Patients already on beta-blocker or nitrates
* Undetermined origin of bleeding from esophageal varix or gastric varix
* Hepatic encephalopathy grade III/IV
* Hepatorenal syndrome
* Hepatocellular carcinoma
* Presence of deep jaundice (serum bilirubin \> 10 mg/dl)
* Uremia
* Cerebrovascular accident
* Cardiorespiratory failure
* Pregnancy and patients not giving informed consent for endoscopic procedures

Primary outcomes:
measure: Bleeding from gastric varix or death
timeFrame: Within 2 years
Secondary outcomes:
measure: Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications
timeFrame: Within 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Shiv K Sarin
state: Delhi
Study officials:
affiliation: G B Pant Hospital, New Delhi, India
name: Shiv K Sarin, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.
Clinical trial NCT06974396: Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage
Official title: Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hemorrhagic Disorders
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Primary purpose :

Compare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor II, V, VII and X assays in two different populations of patients :

* Patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor II or V or VII or X.
* Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment).

Results of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors II, V, VII, X assays. This work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory/center.


Eligibility criteria: Inclusion Criteria:

* Plasma samples from patients addressed to the laboratory of the Strasbourg University Hospital (Strasbourg France) collected and anonymized after completion of the routine testing.
* Patient with an isolated or combined extrinsic pathway factor deficiency (factor II, V, VII, X).

Exclusion Criteria:

* Patient treated with an oral anticoagulant treatment.
* Patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).

Primary outcomes:
measure: Comparison of the sensitivity of several thromboplastin reagents of different origins (animal, human synthetic recombinant and human placental extraction) on prothrombin time and factor II, V, VII and X assays.
timeFrame: Plasma samples were frozen at -80°C within 3 hours of collection and were serially analyzed few weeks later by thawing at 37°C within 2 hours after thawing.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04521296: Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19 Compared to the Placebo
Official title: A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase II/III Study to Evaluate the Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Mild to Moderate COVID-19
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 432
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.


Eligibility criteria: Inclusion Criteria:

* Adults over the age of 19 as of the signed date in written consent
* Subjects with mild or moderate COVID-19 according to RT-PCR test (Total score of NEWS is 0-6 or if one item is 3 points)
* Subjects who have symptoms within 7 days or 72 hours after diagnosis

Exclusion Criteria:

* Subjects who cannot orally administer the investigational products
* Subjects who need administration of immunosuppressants
* Subjects who are allergic or sensitive to investigational products or its ingredients
* Subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening
* Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators

Primary outcomes:
measure: (Part 1) Time to SARS-CoV-2 eradication
timeFrame: Up to 28 days
measure: (Part 2) Time to clinical improvement of subjective symptoms
timeFrame: Up to 14 days
Secondary outcomes:
measure: (Part 1) Rate of SARS-CoV-2 eradication
timeFrame: Days 4, 7, 10, and 14
measure: (Part 1/2) Time to clinical improvement of subjective symptoms
timeFrame: Up to 28 days
measure: (Part 2) Change from baseline of subjective symptom scores
timeFrame: Days 4, 7, 10, 14, 21 and 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05806996: A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
Official title: Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bladder Spasms
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.


Eligibility criteria: Inclusion Criteria:

- Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.

Exclusion Criteria:

* Are unable to grant informed consent or comply with study procedure.
* Allergy or known sensitivity to magnesium or Renacidin.
* Expected or high risk of bladder extravasation.
* Ongoing atrial fibrillation prior to surgery.
* Are undergoing emergency surgery.
* Are pregnant.
* Known hypermagnesemia.
* Patients with neuromuscular weakness (e.g., Myasthenia gravis) due to magnesium's muscle weakening effect.
* Patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects.
* Patients with renal insufficiency, glomerular filtration rate less than 30, since Magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium.
* Patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.

Primary outcomes:
measure: Incidence of bladder spasm
timeFrame: Post-operative, approximately 1 hour
Secondary outcomes:
measure: Incidence of bladder spasm above moderate grade
timeFrame: Post-operative, approximately 4 hours
measure: Treatment for bladder spasms
timeFrame: Post-operative, approximately 4 hours
measure: Patient satisfaction
timeFrame: Post-operative, approximately 4 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gregory Nuttall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01367496: Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose
Official title: An Open-Label, Phase I Study of the Pharmacokinetics and Bioavailability of Single, Ascending Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose in Normal, Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability versus an intravenous dose.


Eligibility criteria: Inclusion Criteria:

1. Subject weight between 60 and 80 kg
2. Subject a non-smoker
3. Subject in good physical health, based on history, physical exam, appropriate laboratory and diagnostics tests at screening with no evidence of clinically significant chronic medical condition.

Exclusion Criteria:

1. Subject with known hypersensitivity to methylnaltrexone, naltrexon or other opioids
2. Subject consuming any prescription medication within the past two weeks, over-the-counter (OTC) products within seven days, any experimental medication within 30 days prior to study screening, or of any drug with a half-life longer then three days within 10 half-lives (\>30 days) of screening
3. Subject consuming barbiturates or other inducers or inhibitors of CYP450 within 3 months of screening
4. Subject with history or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, and renal or other significant chronic illness.

Primary outcomes:
measure: Peak Plasma Concentration of MNTX
timeFrame: 32 days
Secondary outcomes:
measure: Time to Maximum Plasma Concentration (Tmax) of MNTX
timeFrame: 32 days
measure: Clearance of MNTX
timeFrame: 32 days
measure: Half-live of MNTX
timeFrame: 32 days
measure: Volume of Distribution of MNTX
timeFrame: 32 days
measure: Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX
timeFrame: 32 days
measure: Urinary Clearance of MNTX
timeFrame: 32 days
measure: Percentage of MNTX Excreted in Urine
timeFrame: 32 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02881996: The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis
Official title: Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perforated Appendicitis
Keywords: appendicitis
pain
perforation
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate two standard post-operative pain regimens routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia (PCA) to oral pain medications.

Detailed description: To assess pain control, patient and family perception of pain control, time to return of bowel function defined as passage of first flatus (in days), doses of anti-emetic medications, doses of narcotic pain medications, time to toleration of regular diet (in days), narcotic associated adverse effects (nausea, emesis, respiratory depression, constipation), length of stay, and overall hospital cost in admission.

Post-hospitalization the investigators will assess complications including number and reasons for emergency visits and abscess formation, length of post-hospitalization analgesic use, length of post-hospitalization narcotic use, and time to return to school.

Eligibility criteria: Inclusion Criteria:

* All patients ages 2-17 years old undergoing laparoscopic appendectomy at CMH found to have perforated appendicitis.

Exclusion Criteria:

* Non-perforated appendicitis
* Normal appendix at the time of operation or other associated conditions causing abdominal pain
* Patients with history of chronic pain
* Known underlying liver disorders
* Known allergy to pain medication in protocol
* Non-English speaking

Primary outcomes:
measure: Time Until PCA Discontinued After the Operation
timeFrame: 4 days
Secondary outcomes:
measure: Postoperative Duration of Hospital Stay
timeFrame: 1 week
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06921096: Cessation on Internet Addiction in College Students
Official title: Effect of Tai Chi Exercise and Its Cessation on Internet Addiction in College Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Internet Addiction Disorder
Keywords: Internet Addiction Disorder
Tai Chi
Lead sponsor: Chengdu Sport University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to explore the intervention effect of Tai Chi exercise on internet addiction in college students and its maintenance effect after cessation, providing a scientific basis for the application of Tai Chi in internet addiction intervention among college students. Fifty-one non-sports-major college students with mild or moderate internet addiction were randomly divided into a Tai Chi group (n = 23) and a control group (n = 24). The Tai Chi group underwent 12 weeks of Tai Chi exercise, while the control group maintained their regular study schedule without additional physical exercise. The Chinese Internet Addiction Scale and serum dopamine and β-Endorphin levels were assessed at baseline, week 12, and week 16.


Eligibility criteria: Inclusion Criteria:

* Participants aged 18-25;
* CIAS scores of 26-53 (low internet dependence), 54-80 (moderate dependence), or 81-104 (high dependence). Only mild and moderate cases were included;
* non-sports majors; the study followed the Declaration of Helsinki, and all participants understood the purpose and signed consent forms.

Exclusion Criteria:

* Severe IAD (CIAS score \>80);
* Tai Chi practice within 6 months;
* regular exercise habits;
* history of depression/anxiety or undergoing psychological treatment;
* use of medications affecting mental state or neurotransmitter levels.

Primary outcomes:
measure: Internet Addiction Scale Survey
timeFrame: 16 weeks
Secondary outcomes:
measure: Serum Dopamine
timeFrame: 16 weeks
measure: Serum β-Endorphin
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03383796: Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma
Official title: Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiocarcinoma, Perihilar
Surgery
Keywords: Cholangiocarcinoma perihilar
three dimension laparoscopic
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.

This is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. The trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is two years including prearrangement, follow-up and analyses.


Eligibility criteria: Inclusion Criteria:

1. Histologically proven pCCA.
2. Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
3. Preoperative staging work up performed by upper abdomen enhanced CT scan.
4. The subject understands the nature of this trial and willing to comply.
5. Ability to provide written informed consent.
6. Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
2. Subjects undergoing any part for hepatectomy.
3. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4.
4. Synchronous malignancy in other organs.
5. Palliative surgery

Primary outcomes:
measure: Mortality
timeFrame: 24 months
measure: Length of Stay
timeFrame: 24 months
measure: R0 Resection Rate
timeFrame: 24 months
measure: Bile leakage
timeFrame: 24 months
measure: TNM Staging
timeFrame: 24 months
measure: Complication rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: