louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01693848: "Cancersensor" Metastasis Resection
Official title: Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring, of Cancer Therapy: Impact of Surgical Resection of Metastasis on Urinary Excretion of Modified Nucleosides.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal
Cancer
Metastatic
Control
Urine
Nucleosides
Surgery
General anesthesia
Scheduled for surgery
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-09-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital

Brief summary: Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed metastatic colorectal cancer;
* 0 to 3 prior chemotherapy lines; Signed informed consent;
* Good understanding of the protocol and of the follow-up;
* Estimated life expectancy exceeding 3 months;
* At least one measurable metastatic lesion (RECIST criteria);
* Performance Status (WHO) of 0 to 2;
* Good haematological, hepatic and renal functions.

Exclusion Criteria:

* Poor haematological, hepatic or renal functions;
* Uncontrolled chronic disease;
* Serious unhealed wound, ulcer or fracture within the previous month;
* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
* Pregnancy or breast-feeding during the previous month;
* Transmeridian trip of more than 4 time zones within the prior 2 weeks;
* Person with legal restriction to participate into clinical research, according to the current law in France.

Primary outcomes:
measure: Effect of resection of metastasis on urinary excretion of modified nucleosides
timeFrame: 10 days
Secondary outcomes:
measure: Identification of modified nucleosides as biomarkers for colorectal cancer
timeFrame: 10 days
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Paul Brousse hospital
Study officials:
References:
Clinical trial NCT04527848: Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
Official title: Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Holes
Keywords: macular holes
Injections, Intra-Ocular
gases
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted C3F8 (perfluoropropane) versus a large amount of diluted C3F8 versus a small amount of undiluted SF6 (sulfur hexafluoride) versus a large amount of diluted SF6.


Eligibility criteria: Inclusion Criteria:

* pseudophakia
* without previous vitreoretinal surgery
* diagnosed with a full-thickness macula hole on the optical coherence tomography exam.
* duration of symptoms less than 6 months
* inform consent

Exclusion Criteria:

* ocular trauma
* allergy to any of the products used in the study,
* need to travel by plane in the first 60 postoperative days
* myopia over 6 diopters or axial diameter over 26 mm
* retinal dystrophies
* retinal detachment
* abnormal eye shape
* glaucoma
* diabetic retinopathy or other eye comorbidities.

Primary outcomes:
measure: Gas duration
timeFrame: up to 60 days
measure: macula hole closure
timeFrame: 26 weeks
Secondary outcomes:
measure: visual acuity
timeFrame: preoperative, 26 weeks
measure: intraocular pressure
timeFrame: preoperative, 1 day, 26 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: UFPE Ophthalmology
state: PE
Study officials:
affiliation: UFPE
name: Rodrigo PC Lira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05658848: Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction
Official title: Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction Among Women Undergoing in Vitro Fertilization: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility Issues
Lead sponsor: Port Said University
Sponsor class: OTHER
Collaborators: name: Mansoura University
name: Prince Sattam Bin Abdulaziz University
First posted: 2022-12-21
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial


Eligibility criteria: This study will include a non-probability purposive sample of 136 infertile women undergoing IVF recruiting from the outpatient clinics according to the following inclusion criteria:

* age 20 to 45 years
* having a general health score below 28,
* can read and write,

Exclusion criteria include:

* psychiatric problems,
* previous assisted reproductive technology failure,
* leave the intervention for any reason and
* women suddenly experience severe traumatic or psychological events.

Primary outcomes:
measure: Coping strategies
timeFrame: Three Months
measure: Marital Satisfaction
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University hospitals
Study officials:
References:
Clinical trial NCT03356730: Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants
Official title: Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Deficiency, Vitamin D
Keywords: Implants
Vitamin D
Osseointegration
Histomorphometric
Lead sponsor: Universidade de Passo Fundo
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.
Primary purpose: TREATMENT

Brief summary: 1. Title
2. Executive team
3. Research line
4. Summary
5. Research problem
6. Justification
7. Literature review
8. Objectives
9. Materials and methods
10. Dissemination of knowledge generated
11. Schedule of activities
12. Budget
13. References
14. Annexes

Detailed description: This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled clinical trial. Background: Vitamin D replacement could aid in the osseointegration of dental implants. Objective: to evaluate the effect of vitamin D replacement on osseointegration of dental implants in humans. Materials and methods: Twenty individuals with hypovitaminosis D underwent dental miniimplants and randomized to two equal groups for treatment with vitamin D (5000 IU / day) or placebo for 2 months. After two months, the miniimplants will be removed and prepared for histomorphometric analysis, which will evaluate bone implant contact in percentage. Testing the hypothesis that the contact between bone and implant and the bone density in the threaded area in the test group is higher than in the control group. Test t will be used to compare the differences between the groups.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes;
* No medical, temporary or intra-oral contraindications;
* Good general health;
* Need of implant in the maxilla in the posterior region (with a minimum of 5 mm of bone height visualized radiographically) or in mandible in posterior region;
* With vitamin D deficiency / deficiency (considering serum level of ≥ 15 ng / ml at ≤ 25 ng / ml).

Exclusion Criteria:

* Medical, temporary or intrabuccal contraindications;
* Smokers;
* Use of corticoid;
* Post-operative of bariatric surgery;
* Bone height less than 5mm;
* Need for maxillary sinus lift;
* Vitamin supplementation D.

Primary outcomes:
measure: Percentage of bone implant contact
timeFrame: 2 months
Secondary outcomes:
measure: Serum levels of vitamin D (ng/ml)
timeFrame: 2 months
Other outcomes:
Locations:
city: Rondinha
country: Brazil
facility: Isadora Rinaldi
state: Rio Grande Do Sul
Study officials:
affiliation: Universidade de Passo Fundo
name: Maria Salete Sandini Linden
role: STUDY_DIRECTOR
References:
Clinical trial NCT04333030: Study on the Level of Information on the Risks Related to Tobacco of Persons Consulting in Psychiatry and on Access to Aids in Case of Smoking, Comparing With Persons Consulting in Diabetology or in Addictology
Official title: INFO-AIDE-TABAC Study on the Level of Information on the Risks Related to Tobacco of Persons Consulting in Psychiatry and on Access to Aids in Case of Smoking, Comparing With Persons Consulting in Diabetology or in Addictology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consumption, Tobacco
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 310
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: patients who come at :

* Department of Psychiatry for Adults of the Hospital of Versailles of Dr N Bazin (André Mignot in Chesnay): CMP (Centre Médico-psychologique), HDJ (Day Hospital).
* Endocrinology service of Dr JP Beressi of the Hospital of Versailles (André Mignot in Chesnay): consultation, HDJ
* Addictology service CSAPA (Espace Murger) by Dr F Vorspan of the Fernand-Widal Hospital in Paris

Brief summary: this is an observational study that involves providing a questionnaire to patients consulting in psychiatry, addictology (other than tobacco) and endocrinology to assess their knowledge of tobacco risks and access to smoking cessation aids


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years
* Men and women
* who comes for consultation during the study
* Psychiatry on CMP or HDJ, regardless of diagnosis or smoking status
* Endocrinology in consultation or HDJ
* In addictology at CSAPA

Exclusion Criteria:

* Patient unable to complete questionnaire (not speaking French, confused, alcoholics, etc.)
* Refusal to complete questionnaire

Primary outcomes:
measure: to Assess the level of information on tobacco-related risks of patients with questionnaire
timeFrame: at the end of study, average 2 month
measure: to Assess access to smoking cessation aids for smokers and ex-smokers with questionnaire
timeFrame: at the end of study, average 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
city: Paris
country: France
facility: Hôpital Ferdinand Widal
Study officials:
References:
Clinical trial NCT04187430: Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies
Official title: Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clostridium Difficile Infection
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Elena Reigadas Ramirez
name: Patricia Muñoz García
First posted: 2019-12-05
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Positive patients for C. difficile determined by the Microbiology Service of the General University Hospital Gregorio Marañón

Brief summary: The objective of the present study is to derive a high-risk R-ICD prediction rule and a prospective implementation of this prediction rule.

Detailed description: For objectives 1 and 2, a retrospective study of the microbiology database will be carried out and the medical records will be consulted to collect the variables included in Annex 2. The other prediction rules to be compared are those of Cobo et al., Reigadas et al and Gerding et al.

We will review a total of 215 patients according to the calculation of the sample size (see section) A prospective study will also be carried out in which the positive patients for C. difficile determined by the Microbiology Service of the General University Hospital Gregorio Marañón will be included. The medical records of the selected cases will be reviewed. All patients included in the prospective study (Objective 3) will receive the information sheet and consent sheet that they must sign for this study (Annex 1). These patients will be followed and the variables included in Annex 2 will be collected.

Eligibility criteria: Inclusion Criteria:

* For the retrospective cohort, those patients with a positive sample for ICD will be randomly selected from the microbiology database.
* For the prospective cohort: after the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.

Exclusion Criteria:

* Children under 18 years or patients with \<3 faeces not trained in the last 24 hours will not be included.

Primary outcomes:
measure: Create Score
timeFrame: 31 december 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: HGU Gregorio Maranon
Study officials:
References:
Clinical trial NCT01418430: Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
Official title: HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2011-08-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of the combination of CHOP plus daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed ATLL requiring treatment

   1. Frank acute leukaemia or lymphoma subtypes
   2. Chronic and smouldering cases should be considered if they are symptomatic and require therapy, or there is evidence of disease progression
2. No previous treatment with anthracycline based cytotoxic chemotherapy

   a. Patients may have received interferon and /or zidovudine and/or non-anthracycline based therapy
3. Age 18-75 years
4. Written informed consent

Exclusion Criteria:

1. HIV 1 or 2 positivity
2. Pregnancy or breast-feeding
3. Concomitant chemo-radiotherapy
4. Prior hepatic or renal insufficiency with a bilirubin or transaminases greater than 5 times the normal range or a creatinine greater than 150μmol/l (not related to hypercalcaemia) following rehydration
5. Other concomitant neoplasms not related to HTLV-I
6. Cardiac or respiratory insufficiency with an ECOG score of greater than 3
7. Any serious active uncontrolled infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT05396430: Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia
Official title: Early Recovery After Cesarean Delivery: Duration of Urinary Catheter Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Retention
Cesarean Section Complications
Lead sponsor: Women's Hospital HUS
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The parturients are randomized into 3 different treatment arms with different duration of planned urinary catheter treatment
Primary purpose: TREATMENT

Brief summary: In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.

Detailed description: In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.

Eligibility criteria: Inclusion Criteria:

* After informed consent, signed the participation form (volunteered for the study)
* Cesarean section
* Spinal anesthesia

Exclusion Criteria:

* Prior neuraxial analgesia (epidural or spinal) for attempted labour

Primary outcomes:
measure: Success of spontaneous voiding of bladder
timeFrame: 6-12 hours after removal of the urinary catheter
Secondary outcomes:
measure: Amount of residual urine in the bladder
timeFrame: 6-12 hours after removal of the urinary catheter
measure: Need for standard in-house medications to help spontaneous voiding of the bladder
timeFrame: 6-12 hours after removal of the urinary catheter
measure: Need for re-cathterization of the bladder
timeFrame: 6-12 hours after removal of the urinary catheter
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS/Women's hospital dept of obstetrics
Study officials:
References:
Clinical trial NCT01019330: Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days
Official title: Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radial Artery Occlusion
Keywords: radial vs femoral
radial artery cardiac catheterization
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 243
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at Creighton University Medical Center Cardiac Catheterization laboratory for either radial or femoral cardiac catherization

Brief summary: Cardiac catheterization has traditionally been performed via access to the arterial circulation from the femoral artery located in the groin. As an alternative to this approach, the radial artery, located in the arm, is gaining wider use in clinical practice. Multiple studies have demonstrated that cardiac catheterization via the radial approach has a very low complication rate, in the short term. This study is intended to determine if there are any differences in the long term complication rate between radial artery cardiac catheterization as compared with femoral artery cardiac catheterization.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* 19 years old or older
* candidate for radial or femoral cardiac catheterization

Primary outcomes:
measure: To determine if there is a difference in complication rate measured at 30 days between radial and femoral catheterization
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Omaha
country: United States
facility: The Cardiac Center at Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Michael White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01723930: Transpulmonary Gradient After Cardiac Surgery Under Cardiopulmonary Bypass
Official title: Transpulmonary Gradient of Inflammation Biomarkers and Pulmonary Vascular Resistance in Acute Respiratory Failure After Cardiac Surgery Under Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2012-11-08
Enrollment: 30
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: Recruitment concerns only patients with high risk of postoperative respiratory failure (SLIP score \> 22).

Brief summary: Get a better understanding of the pathophysiological processes of acute respiratory failure following cardiopulmonary bypass to initiate timely therapies targeted on a cell line.

Demonstrate that there is a relationship between increased transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery under cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* Patient man or woman \> 18 y.o.
* Patient has signed informed consent prior to the study
* Patient affiliated to a social security administration
* Patient operated on for cardiac surgery at the University Hospital of Strasbourg.
* Patient at high risk for postoperative respiratory failure defined by a SLIP score (Kor et al.) ≥ 22 Kor:

  * High-risk cardiac intervention under cardiopulmonary bypass (19 pts)
  * COPD (10 pts)
  * Diabetes (6 pts)
  * gastroesophageal reflux (7 pts)
  * Alcohol abuse (11 pts)
* Scheduled use of a pulmonary artery catheter and a left atrial catheter

Exclusion Criteria:

* Inability to obtain informed consent from the patient and / or unable to give informed patient information (difficulty understanding ...)
* Urgent surgery (\<24h)
* Acute heart failure
* Patient ventilated preoperatively
* Allergy to Latex
* Persons deprived of liberty or under judicial protection
* Patient placed under guardianship
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance
timeFrame: during the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital
state: Alsace
Study officials:
References: