louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05186402: Predictive Factors of Morbidity and Mortality and Overall Survival of Patients With Gastric Cancer : a Case Series
Official title: Predictive Factors of Morbidity and Mortality and Overall Survival of Patients With Gastric Cancer : a Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Mortality of Gastric Cancer
Overall Survival of Patients With Gastric Cancer
Keywords: gastric cancer mortality, gastric cancer treatment
Lead sponsor: Centre Hospitalier Universitaire Ibn Rochd
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study enrolled all the patients who underwent gastric resection for gastric adenocarcinoma

Brief summary: This is a retrospective study extending over a period of three years concerning patients with gastric adenocarcinoma hospitalized in the digestive cancer surgery and liver transplant service of the IBN ROCHD University Hospital Center in Casablanca. Evaluation from a series of 80 cases of gastric adenocarcinomas, follow-up to determine the prognostic factors influencing mortality, morbidity and survival.


Eligibility criteria: Inclusion Criteria:

* patients with gastric cancer

Exclusion Criteria:

* patients with benign tumors or other pathologies requiring gastric resection

Primary outcomes:
measure: Overall survival
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06162702: Clinical Study of Fecal Microbiota Transplantation in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
Official title: To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Intestinal Bacterial Overgrowth
Fecal Microbiota Transplantation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Small intestinal bacterial overgrowth (SIBO) is defined as the presence of excessive numbers of bacteria in the small bowel causing gastrointestinal (GI) symptoms. These bacteria are usually coliforms, which are typically found in the colon and include predominantly Gram-negative aerobic and anaerobic species that ferment carbohydrates producing gas .Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of SIBO.


Eligibility criteria: Inclusion Criteria:

* Patients with a positive breath test result upon initial admission.
* Patients presenting with abdominal symptoms.
* Patients who have stool and small intestinal fluid samples available before and after FMT.

Exclusion Criteria:

* Patients with gastrointestinal malignancies.
* Patients with a history of gastrointestinal surgery.
* Patients on long-term probiotic use.
* Patients with a history of extensive antibiotic use.

Primary outcomes:
measure: Incidence of adverse events (Assessing the safety of FMT in patients with SIBO)
timeFrame: 7 days, 1 month
measure: Number of Patients with gastrointestinal symptom scores
timeFrame: 7 days, 1 month
measure: Investigating the impact of FMT on the colonic and small intestinal microbiota.
timeFrame: 7 days, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Study officials:
References:
Clinical trial NCT01952002: Clinical Safety for the Inspiratory Muscle Training
Official title: CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Lung Disease
Keywords: Blood Pressure
heart rate
electrocardiogram
Cardiac arrhythmias
respiratory exercise
Lead sponsor: Clínica de Medicina do Exercício
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 21
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients regularly attending a supervised exercise program

Brief summary: The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic responses during an inspiratory muscle training session during a single cardiopulmonary rehabilitation session program. An electrocardiogram will be continuously recorded and the heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately after a single inspiratory muscle training (IMT) session, consisting of two series of 15 cycles, with one-minute intervals between sets and an initial load of at least 30% of the initial maximal inspiratory pressure (MIP).


Eligibility criteria: Inclusion Criteria:

* Patients regularly attending a supervised exercise program
* Patients were already performing the IMT in their usual supervisioned exercise sessions

Exclusion Criteria:

* cognitive impairment

Primary outcomes:
measure: abnormal clinical responses
timeFrame: One day
Secondary outcomes:
measure: hemodynamic (blood pressure and heart rate) responses
timeFrame: one day
measure: electrocardiographic pattern changes
timeFrame: one day
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Clinimex - Clínica de Medicina do Exercício
Study officials:
References:
Clinical trial NCT00002002: A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
Official title: A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: Trimethoprim-Sulfamethoxazole Combination
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Diagnosis of PCP.
* Fit the CDC definition of AIDS.
* Be receiving intravenous or oral trimethoprim / sulfamethoxazole (Bactrim, Septra) in doses of = or \> 15mg/kg/day of the trimethoprim component.
* Be receiving = or \< 48 hours of trimethoprim / sulfamethoxazole (TMP / SMX) prior to randomization.
* Must sign informed consent in accordance with FDA guidelines.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Cannot take oral medications.
* Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.

Concurrent Medication:

Excluded:

* Continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.

Patients with the following are excluded:

* Cannot take oral medications.
* Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.

Prior Medication:

Excluded:

* \> 48 hours of trimethoprim / sulfamethoxazole prior to randomization.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
Study officials:
References:
citation: Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7. doi: 10.1093/infdis/170.4.912.
Clinical trial NCT02314702: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
Official title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Joint Disease
Keywords: Osteoarthritis
Avascular necrosis
Ankylosis
Protrusio acetabuli
Painful hip dysplasia
Rheumatoid arthritis
Correction of functional deformity
Revision procedures
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been previously implanted with PROFEMUR® L Revision Femoral Components

Brief summary: MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.


Eligibility criteria: Inclusion Criteria:

* Has undergone revision total hip arthroplasty
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Subjects currently enrolled in another clinical study
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration

Primary outcomes:
measure: Number of participants who require a revision
timeFrame: 10 years post-operative
Secondary outcomes:
measure: Patient functional score on the the Oxford Hip Score instrument
timeFrame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
measure: Patient functional score on the EQ-5D-3L instrument
timeFrame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
Study officials:
References:
Clinical trial NCT03679702: A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome
Official title: A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexual Dysfunction
Lead sponsor: Southern California Center for Sexual Health and Survivorship Medicine
Sponsor class: OTHER
Collaborators: name: Viveve Inc.
First posted: 2018-09-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to SSRI Sexuality Syndrome.


Eligibility criteria: Inclusion Criteria:

* Currently using SSRI for 3 months at a stable dose

Exclusion Criteria:

* Pregnant, currently breastfeeding, or breast-fed within the last 6 months
* Has any implantable electrical device that could potentially be affected by use of radiofrequency.

Primary outcomes:
measure: Safety - Adverse Events
timeFrame: baseline to 6 month
Secondary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: baseline to 3 and 6 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Southern California Center for Sexual Health and Survivorship Medicine
state: California
Study officials:
References:
Clinical trial NCT04195802: Self-administered Questionnaire to Evaluate Salt and Potassium Diet of Patients Followed in Nephrology
Official title: Self-administered Questionnaire to Evaluate Salt and Potassium Diet of Patients Followed in Nephrology - UniverSEL Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephropathy, Chronic Tubulointerstitial
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined

Brief summary: The aim of the study is to create a self-questionnaire to evaluate sodium and potassium diet in chronic kidney disease patients.

Questionnaires will be compared to 24h sodium and potassium urinary excretion (reference) A Bayesian network and a multiple regression will be used to select the most relevant items


Eligibility criteria: Inclusion Criteria:

* Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined
* Consent informed agreement

Exclusion Criteria:

* Do not want to participate

Primary outcomes:
measure: The aim of the study is to create a self-administered questionnaire to evaluate sodium and potassium consumption in chronic kidney disease patients.
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Service de néphrologie - HTA - Dialyse
Study officials:
affiliation: Service de néphrologie - HTA - Dialyse
name: Jean Pierre FAUVEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04198402: Microbiotic Analysis in Digestive Endocrine Tumors
Official title: Microbiotic Analysis in Digestive Endocrine Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Digestive Neuroendocrine Tumor
Fecal Microbiota
Bacterial Signature
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Naive patient with digestive neuroendocrine tumor (pancreas (cytology or histology per endoscopy or on surgical specimen) or small intestine), secreting or not, going to receive Lanreotide treatment as the first line therapy for their disease.

Brief summary: Incidence of digestive neuroendocrine tumors are increasing. Analysis of individual microbiota is a way to explore new neoplastic mechanisms, tumor identification and therapeutic orientations. This prospective pilot study aims to describe fecal bacterial phylogeny of patients with digestive neuroendocrine tumor.

Bacterial genomic signature will be recorded at initiation of Lanreotide treatment in naive patient with digestive neuroendocrine tumor (pancreas or small intestine), metastatic or locally advanced, as well as after one year follow up.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* naive patient with digestive neuroendocrine tumor (pancreas (cytology or histology per endoscopy or on surgical specimen) or small intestine), secreting or not, initiating a extended release Lanreotide treatment
* registered with a social security scheme

Exclusion Criteria:

* medical contraindication to somatostatine analogs use
* history of extended release somatostatine analogs treatment
* antibiotic use or colonoscopic purge in the last 3 weeks preceding fecal sample
* pregnant or breastfeeding women
* person requiring tutorship, guardianship, or person legally protected

Primary outcomes:
measure: bacterial genomic signature
timeFrame: Baseline visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01152502: Paracetamol Metabolism in Post Operative Conditions
Official title: Paracetamol Metabolism in Post Operative Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Surgery and Treatment Post Operative With Paracetamol During 4 Days
Keywords: Post operative conditions, paracetamol metabolites
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Defined population

Brief summary: Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)

Detailed description: D-15 to D0: selection

* patient information and non-opposition obtained
* inclusion and non inclusion criteria check
* clinical exam

D-1 to D0 : 24 hours diuresis

D0 : operation day

Before anesthesia :

* urine collection (paracetamol metabolites dosage)
* blood sampling (glutathion and liver function test)

Surgery:

* 1st paracetamol intake before closing
* Then administration every 6 hours

D1 to D4 :

* 24 hours urine collection (metabolites dosage)
* blood sampling et D1 and D4(glutathion and liver function test)

D5 : final clinical exam

Eligibility criteria: Inclusion Criteria:

* aortic surgery
* treatment with intraveinous paracetamol (4 grammes daily during 4 days)
* patient agrees to participate

Exclusion Criteria:

* - patient disagrees
* paracetamol contra-indication
* paracetamol intake 5 days before surgery

Primary outcomes:
measure: Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)
timeFrame: during 4 days therapeutic intake
Secondary outcomes:
measure: - Follow-up of glutathion concentration during 4 post operative days
timeFrame: during 4 post operative days
measure: Monitoring of liver function
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Eric SCHNEIDER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03245502: The Effect of Blood Transfusion on Venoarterial PCO2 Difference in Cardiac Surgery
Official title: The Effect of Blood Transfusion on Venoarterial PCO2 Difference in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Procedure Complication
Keywords: tissue oxygenation
Lead sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-08-10
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-75 years cardiac surgery patients

Brief summary: Venoarterial CO2 difference(delta PCO2), lactate, central venous oxygen saturation(ScVO2) will be recorded in several steps in coronary artery bypass graft and valvular cardiac operations. The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.

Detailed description: Preoperative creatinine values, demographic data, comorbidities will be recorded in ASA I-II elective coronary artery and valvular cardiac surgery patients. Intraoperative delta PCO2, lactate, ScVO2 will be recorded in several steps. The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.

Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery, stable cardiac function

Exclusion Criteria:

* Clinical signs of heart failure, symptomatic cerebral or peripheral failure, uncontrolled diabetes mellitus

Primary outcomes:
measure: Complication
timeFrame: 5 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Turkiye Yuksek Ihtisas Education and Research Hospital
Study officials:
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
name: Demet Bölükbaşı, Specialist
role: STUDY_CHAIR
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
name: Sema Turan, Asc prof
role: STUDY_DIRECTOR
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
name: Dilek Kazancı, Asc prof
role: STUDY_CHAIR
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
name: Sultan Sevim Yakın, Specialist
role: STUDY_CHAIR
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
name: Hija Yazıcıoğlu, Asc Prof
role: STUDY_CHAIR
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
name: Aysegül Özgok, Prof
role: STUDY_DIRECTOR
References: