louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01842464: Sacro-Spinous Ligaments Anterior Apical Anchoring
Official title: Sacro-Spinous Ligaments Anterior Apical Anchoring for Needle-Guided Mesh in Advanced Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2013-04-29
Enrollment: 44
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients suffering advanced pelvic organ prolapse with anterior predominance and apical supportive defect, reffered to mesh reconstruction.

Brief summary: Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.

Detailed description: Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.

Eligibility criteria: Inclusion Criteria:

* Pelvic Floor Prolapse \> Gr 2,
* Anterior \> Posterior defect,
* Apical Supportive Defect

Exclusion Criteria:

* Active Pelvic Inflammation,
* Patient Refusal

Primary outcomes:
measure: The Change With Distance Between the Vaginal Apex and the Introitus
timeFrame: One year
measure: Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring
timeFrame: one year
measure: Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Western Galilee MC
name: Menahem Neuman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173264: Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Monoclonal Gammopathy
Tuberculosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to determine whether the monoclonal protein in patients with tuberculosis and monoclonal gammopathy has anti-tuberculous activity, and whether genes coding their monoclonal proteins show characteristic mutations.

Detailed description: Monoclonal immunoglobulins arise from abnormal proliferation of a single clone of plasma cells. They are composed of a single light and/or heavy chain class, in contrast to polyclonal immunoglobulins. They may occur in malignant lymphoproliferative diseases, such as multiple myeloma, Waldenstrom's macroglobulinemia, lymphoma, chronic lymphocytic leukemia, amyloidosis, or more benign conditions such as monoclonal gammopathy of undetermined significance (MGUS). Recently we have observed monoclonal gammopathy occurring in patients with tuberculosis. Whether tuberculous infection plays a role in the production of monoclonal protein, and whether the monoclonal immunoglobulins possess anti-tuberculous activity are unknown. In the current project we plan to study: (1) whether the monoclonal immunoglobulin developed in patients with tuberculosis reacts with tuberculous antigen (using ELISA), and (2) whether the VH gene sequence analysis of such patient shows different mutation patterns (indicating the presence of intraclonal mutation variation) or not. If there is no intraclonal mutation variation, it suggests that the plasma cell clone is not under current exposure to the mutator, and the production of monoclonal gammopathy is probably not related to tuberculous infection. If, however, the VH gene sequence analysis shows the presence of intraclonal mutation variation, it indicates that the plasma cell clone is continuously under the influence of the mutator. In such case the production of monoclonal protein may be related to tuberculous infection.

Eligibility criteria: Inclusion Criteria:

* Monoclonal Gammopathy with Tuberculosis

Exclusion Criteria:

* No

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Laboratory Medicine, National Taiwan Univeristy Hospital
Study officials:
affiliation: Department of labrotoary medicine,National Taiwan University Hospital
name: LINA LEE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01169064: Topical Silver for Prevention of Wound Infection After Cesarean Delivery
Official title: Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound Infection
Keywords: Wound infection prevention
Silver-containing surgical dressing
Cesarean delivery infection prevention
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 475
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.


Eligibility criteria: Inclusion Criteria:

* Cesarean delivery with pfannenstiel incision

Exclusion Criteria:

* Incision other than pfannenstiel
* Silver allergy
* Inability to provide informed consent

Primary outcomes:
measure: Silver Treatment Efficacy
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Infection Rate Adjusted for Maternal BMI
timeFrame: 6 weeks postpartum
measure: Patient Dressing Cost
timeFrame: Postoperative
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Kelly A. Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00937664: Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Solid Tumors
Advanced Solid Malignancies
Keywords: Phase I
cancer
solid tumors
advanced solid malignancies
dose escalation
combination treatment
CHK inhibitor
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.


Eligibility criteria: Inclusion Criteria:

* Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.
* Must be suitable for treatment with gemcitabine
* Relatively good overall health other than cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells).
* Poor liver or kidney function.
* Serious heart conditions

Primary outcomes:
measure: Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
timeFrame: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2
Secondary outcomes:
measure: Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine
timeFrame: According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1
measure: Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Every 2-3 cycles
Other outcomes:
Locations:
city: Minami-ku
country: Japan
facility: Research Site
state: Fukuoka
Study officials:
affiliation: AstraZeneca
name: Peter Langmuir, MD
role: STUDY_DIRECTOR
affiliation: National Hospital Organization Kyushu Cancer Center
name: Takashi Seto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00300664: A Randomized Trial of Human Growth Hormone (hGH) vs Placebo in Intensively Treated Haemato-Oncology Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Myeloma
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2006-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: About 90% of patients with haemato-oncologic malignancy lose their body muscle mass and also lose weight either due to chemotherapy induced nausea/vomiting or the high catabolic state due to fever, sepsis or chemotherapy. This impacts tremendously on the days in hospital and also on the treatment-related complications. Studies with Human Growth hormone (hGH) have shown that it increases lean body mass in adult patients with AIDS and animal models of cancer. At the same time, in vitro studies have shown that hGH has no effect on tumor cell growth. This study is designed to see if the use of hGH in immunocompromised patients with haematological malignancies prevents the loss of muscle mass and weight loss to some extent.

This will be a blinded 1:1, randomised study including 150 patients whereby the patients will either receive hGH or a placebo. The doctors and the nurses will not know what drug the patient is receiving. Both hGH and the placebo will be given intravenously (if patients are receiving other intravenous antibiotics or haemopoietic support ) or subcutaneously (if platelets are above 20 x 109/L) The treatment will start on the first day of treatment and continue for 6 weeks.


Eligibility criteria: Inclusion Criteria:

- Age \>= 18 years 2. Patients with haematological malignancies receiving neutropenia (\< 0.5 x 109/L) inducing chemotherapy (+/- TBI) requiring hospitalisation.

3. Negative pregnancy test if the patient is of childbearing potential 4. Informed consent

Exclusion Criteria:

* . Previous treatment with growth hormone 2.Unstable psychiatric conditions 3. Uncontrolled endocrine disorders 4.Chronic severe liver disease: AST or ALT\>3x upper limit of normal range 5. Chronic severe renal disease: creatinine\>150 µM or repeated positive test for haematuria or proteinuria 6. Severe congestive heart failure 7. Aortic stenosis associated with clinical symptoms eg syncope of angina pectoris 8. Hypertrophic cardiomyopathy 9. Uncontrolled hypertension (diastolic blood-pressure \> 105 mm Hg) 10. Diabetes mellitus that is not well controlled with insulin/antidiabetic drugs 11. Severe respiratory disease 12. Known or suspected allergy to growth hormone or any of its constituents 13. History of drug or alcohol abuse within two years prior to study enrolment 14. Exposure to another investigational medication or device currently or within three months prior to enrolment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Ray Powles, FRCP, FRCPath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284164: Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
Official title: An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: ContraVir
Sponsor class: UNKNOWN
First posted: 2017-09-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tenofovir exalidex (TXL)
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex

Detailed description: This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex

Eligibility criteria: Inclusion Criteria:

* Age: 18 years of age and over
* Capable of giving written informed consent
* Capable of completing study requirements

Exclusion Criteria:

* Positive result for HIV, HBV, or HCV
* History or medical condition which could impact patient safety
* Current or past abuse of alcohol or drugs
* Participation in another clinical trial within the past 30 days

Primary outcomes:
measure: Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
timeFrame: up to six days post dose
Secondary outcomes:
measure: Evaluation of the adverse events for TXL in RI subjects
timeFrame: up to six days post dose
measure: Evaluation of safety labs for TXL in RI subjects
timeFrame: up to six days post dose
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: ContraVir Pharmaceuticals
name: John Sullivan-Bolyai, MD, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT00762164: Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol
Official title: Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Statins
Ezetimibe
Lead sponsor: Bronx VA Medical Center
Sponsor class: FED
First posted: 2008-09-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.


Eligibility criteria: Inclusion Criteria:

* Subjects with an LDL-cholesterol greater than 100 mg/dL
* Patients willing and able to provide signed informed consent

Exclusion Criteria:

* Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
* Patients intolerant of statins
* Patients receiving ezetimibe
* Patients intolerant of ezetimibe
* Patients receiving a niacin preparation
* Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
* Cancer undergoing active treatment
* Creatinine clearance \< 50 ml/minute
* Active liver disease or persistent elevation of SGOT or SGPT \> 2 times the upper limit of normal level
* Participation in any clinical study within the last 30 days
* Drug addition or alcohol abuse within the past 6 months
* Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
* Active use of macrolide antibiotics or verapamil
* Consumption of grapefruit juice on a daily basis
* Patients unwilling or unable to provide informed consent
* Patients with poor compliance
* Women of childbearing potential

Primary outcomes:
measure: LDL Cholesterol
timeFrame: 6 weeks
Secondary outcomes:
measure: Total Cholesterol
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx VA Medical Center
state: New York
Study officials:
affiliation: Bronx VA Medical Center
name: Lawrence Baruch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05830864: Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus
Official title: Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus (I-Seizure)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refractory Status Epilepticus
Keywords: Isoflurane
Lead sponsor: Hopital of Melun
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with eligibility criteria in the sites of study will be included int the study

Brief summary: Isoflurane might be used as anticonvulsive therapy in refractory status epilepticus. The aim of the study is to assess the efficiency of Isoflurane in this indication.

Detailed description: Investigators will collect in 4 ICUs the data from consecutive patients hospitalized between january 2016 and january 2023. Included patient were those treated by Isoflurane for refractory status epilepticus.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years, hospitalized in ICU between 2016-01-01 and 2023-01-01, suffering refractory status epilepticus treated by inhaled Isoflurane as third anticonvulsive therapy

Exclusion Criteria:

* post-anoxic refractory status epilepticus after cardiac arrest, withdrawal of consent for medical data use

Primary outcomes:
measure: rate of crisis control
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beuvry
country: France
facility: Ch Bethune Beuvry
city: Brest
country: France
facility: CHU Brest
city: Melun
country: France
facility: GH Sud Ile de France, Hôpital de Melun-Sénart
city: Toulon
country: France
facility: CH Toulon - Sainte Musse
Study officials:
affiliation: GHSIF MELUN
name: SEBASTIEN JOCHMANS, MD
role: STUDY_DIRECTOR
References:
citation: Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.
citation: Stetefeld HR, Schaal A, Scheibe F, Nichtweiss J, Lehmann F, Muller M, Gerner ST, Huttner HB, Luger S, Fuhrer H, Bosel J, Schonenberger S, Dimitriadis K, Neumann B, Fuchs K, Fink GR, Malter MP; IGNITE Study Group, with support from the German Neurocritical Care Society (DGNI). Isoflurane in (Super-) Refractory Status Epilepticus: A Multicenter Evaluation. Neurocrit Care. 2021 Dec;35(3):631-639. doi: 10.1007/s12028-021-01250-z. Epub 2021 Jul 20.
Clinical trial NCT00151164: Thymic Tolerance in Pediatric Heart Transplantation
Official title: Thymic Tolerance in Pediatric Heart Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Transplantation
Keywords: transplantation tolerance
thymus
bone marrow
pediatric heart transplantation
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 2005-09-08
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators hypothesize that injecting donor bone marrow cells into the recipient thymus gland at the time of heart transplantation in children will prove to be feasible and safe. They further hypothesize that recipients receiving donor bone marrow will experience less acute rejection events with reduced long-term requirements for immunosuppressive medications when compared to controls who do not receive marrow but who are managed under an identical immunosuppressive protocol.


Eligibility criteria: Inclusion Criteria:

* Less than 21 years of age at listing
* Listed for primary orthotopic heart transplant at Children's Hospital of Pittsburgh, between 04/01/04 and 03/31/08

Exclusion Criteria:

* History of prior transplant
* Listed for multi-organ transplant
* Sensitized against human HLA tissue types
* Documentation of total thymomectomy during a prior surgery

Primary outcomes:
measure: Determine if intra-thymic inoculation of donor bone marrow cells at time of heart transplantation in children will reduce frequency of acute rejection as well as long-term requirements of immunosuppressive medications when compared to control patients
Secondary outcomes:
measure: Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical School
name: Steven A. Webber, MBChB
role: PRINCIPAL_INVESTIGATOR
References: