louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01975740: Manual Diaphragm Release Technique Effects On Tidal Volume in Elderly
Official title: Manual Diaphragm Release Technique Effects On Tidal Volume And Upper Rib Cage Contribution During Quiet Breathing In Elderly: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Question: Does manual diaphragm release change kinematics and respiratory function of elderly subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.

Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control Group (CG) and 08 in the Intervention Group (IG).

Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten deep breaths, with a one minute interval between them. The CG underwent a sham protocol (light touch), with same sets and time of interval.

Outcome measures: The groups were evaluated using spirometry, manovacuometry and optoelectronic plethysmography (OEP), in that order, before and immediately after the intervention.


Eligibility criteria: Inclusion Criteria:

* over 60 years of age;
* a body mass index (BMI) below 30 kg/m2
* non-smokers, self-declared sedentary;
* presenting a forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted;
* the ratio between these variables (FEV1/FVC) greater than 70% in spirometry

Exclusion Criteria:

* Showed the inability to understand verbal commands in the evaluation.

Primary outcomes:
measure: Compartmental chest wall distribution
timeFrame: before first session
Secondary outcomes:
measure: Maximal inspiratory and expiratory pressures
timeFrame: Before first session
measure: Pulmonary Function
timeFrame: Before first session
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT06213740: Validation of a New Simplified Scoring System for Acute Calculous Cholecystitis
Official title: Validation of a New Simplified Scoring System (ACME) for Acute Calculous Cholecystitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Keywords: Acute Cholecystitis
Cholecystectomy
Tokyo Guidelines
Postoperative Complications
Mortality
High-risk patient
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the admisions with the inclusion criteria during 2017 and 2021.

Brief summary: Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is \<1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is this validation of the new simplified scoring system for mortality in ACC.

Detailed description: This is a retrospective single-center observational study of 387 adults with ACC during 2 non-consecutive years (2017/2021), including baseline demographic characteristics, comorbidity severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines' severity classification and the new ACME Score. The primary outcome is to study the prediction of mortality of ACME score. Secondary outcomes include complications following Clavien-Dindo's classification, C-statistic, and ROC Curves.

Eligibility criteria: Inclusion Criteria:

* The selected patients were among those who had acute cholecystitis according to the TG18 or received a diagnosis of ACC in the histopathological report.

Exclusion Criteria:

* The study case definition was a "Pure ACC", therefore, patients with any other concomitant diagnosis potentially influencing outcome such as acute pancreatitis, acalculous cholecystitis, chronic cholecystitis, acute cholangitis, postoperative cholecystitis, gallbladder adenocarcinoma and those who had undergone cholecystectomy as a prophylactic measure in another intervention were excluded from the study.

Primary outcomes:
measure: Mortality
timeFrame: 2017 and 2021
Secondary outcomes:
measure: Complications
timeFrame: 2017 and 2021
Other outcomes:
Locations:
city: Cerdanyola del Vallès
country: Spain
facility: Ana María González Castillo
state: Barcelona
Study officials:
References:
Clinical trial NCT00899340: Protein Expression in Tumor Tissue Samples From Patients With Cancer of the Oropharynx
Official title: Protein Expression Profiles in Oropharyngeal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: recurrent squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors plan better treatment for patients with cancer of the oropharynx.

PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from patients with cancer of the oropharynx.

Detailed description: OBJECTIVES:

* To investigate if some of the differences in gene expression are also reflected at the protein level.
* To determine whether differences in gene expression that are also reflected at the protein level can be used to develop markers for early detection and disease surveillance.
* To identify targets for therapy.

OUTLINE: Archived tumor tissue samples are analyzed for expression of standard immunohistological markers (e.g., p16, p53, and Ki-67) as well as expression of genes identified in a previous gene expression study. Protein expression data are tested for clinical and demographic correlates and compared with gene expression data.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of squamous cell carcinoma of the oropharynx
* Tumor tissue samples available from Vanderbilt Head and Neck Tumor Repository and Vanderbilt Pathology archives

Exclusion Criteria:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Development of biomarkers for early detection or recurrence surveillance
timeFrame: after 7 months of tissue collection
measure: Identification of therapeutic targets and individualization of treatment based on the biology of squamous cell carcinoma of the oropharynx
timeFrame: after 7months of tissue collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara Murphy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04449640: Uterine Rupture After Hysteroscopic Septum Resection
Official title: Uterine Rupture in Pregnancy After Hysteroscopic Septum Resection: a Twenty-year Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septum; Uterus
Rupture, Uterine
Keywords: Hysteroscopy
Uterine septum
Complications
Uterine perforation
Pregnancy
Uterine rupture
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
name: Università degli Studi di Brescia
First posted: 2020-06-29
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who underwent previous hysteroscopic septum resection.

Brief summary: To date, several studies have already confirmed a positive effect of hysteroscopic metroplasty on reproductive outcomes in primary infertile women affected by uterine septum, the most common uterine malformation. Nevertheless, very few data are available about the risk of uterine rupture in subsequent pregnancies after hysteroscopic septum resection (HSR). In order to shed about this element, we will retrospectively review the cases of uterine rupture in our setting in the last twenty years, identify which of them had previously undergone HSR, and evaluate the main clinical characteristics for each case.


Eligibility criteria: Inclusion Criteria:

* Previous hysteroscopic septum resection;
* Pregnancy;
* Uterine rupture.

Exclusion Criteria:

* Previous myomectomy (regardless of the surgical technique) or cesarean section.

Primary outcomes:
measure: Uterine rupture
timeFrame: Retrospective analysis over the last twenty years.
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Italy
facility: Antonio Simone Laganà
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: University of Ljubljana
name: Helena Ban Frangež, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03505840: The Value of Placental Vascularization and Placental Volume in Pregnancy in APLS
Official title: TheValue of Placental Vascularization Indices and Placental Volume in Pregnancies With Antiphospholipid Syndrome for Prediction of Neonatal Outcome"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antiphospholipid Syndrome in Pregnancy
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-04-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Singleton pregnancy.

* Gestational age of 34-37 weeks.
* Pregnant women with antiphospholipid syndrome

Brief summary: Antiphospholipid antibodies are autoantibodies directed against phospholipid-binding proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin antibodies (aCL)

Detailed description: APLS can be primary when no evidence of autoimmune disease is found, or secondary to autoimmune processes like systemic lupus erythematous (SLE) in a 40% of the cases.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy.

  * Gestational age of 34-37 weeks.
  * Pregnant women with antiphospholipid syndrome

Exclusion Criteria:

* Twin or multiple pregnancies.
* Congenital fetal anomalies.
* Gestational age of less than 34.
* Gestational age of more than 37.
* Women with placental or umbilical artery anomalies.
* Antepartum hemorrhage (placental abruption, placenta previa and vasa previa).
* Posterior placenta.
* History of rupture of membrane.
* Patient refusal or fall outs.

Primary outcomes:
measure: The number of participants who will have impaired placental doppler indices
timeFrame: within 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04292340: Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of COVID-19
Official title: The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus
Keywords: Plasma transfusion
Coronavirus
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2020-03-03
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants received anti-SARS-CoV-2 inactivated convalescent plasma

Brief summary: There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.


Eligibility criteria: Inclusion Criteria:

* The participants were diagnosed as COVID-19;
* Participants received anti-SARS-CoV-2 inactivated convalescent plasma
* Written the informed consent.

Exclusion Criteria:

* Participants lacked detailed medical history

Primary outcomes:
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1
timeFrame: 1 day after receiving plasma transmission
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
timeFrame: 3 days after receiving plasma transmission
measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
timeFrame: 7 days after receiving plasma transmission
measure: Numbers of participants with different Clinical outcomes
timeFrame: From receiving plasma transmission to 4 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 4 weeks after receiving plasma transmission
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Hongzhou Lu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04253340: Study of a Bone Assessment Technique, Bone Mineral Analyser, Concerning the Prediction of Improvement in Bone Status After an Infusion of Zoledronic Acid in Osteoporotic Women
Official title: Study of a Bone Assessment Technique, Bone Mineral Analyser, Concerning the Prediction of Improvement in Bone Status After an Infusion of Zoledronic Acid in Osteoporotic Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: * Collection of epidemiological data
* Biological assessment as part of routine care.
* Measurement of the Hurst coefficient at D0
* Measurement of bone density and TBS on D0
* Zoledronic acid infusion the month following inclusion
* phone call at 1 month (observance of zoledronic acid)
* Measurement of bone density, calculation of the Hurst coefficient at M12


Eligibility criteria: Inclusion Criteria:

* Women \< 85 years old
* Postmenopausal women (amenorrhea for more than 12 months), a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).
* Post-menopausal osteoporosis with one or more severe fractures (upper end of the humerus, femur, or tibia; 3 adjacent ribs; lower end of the femur; thoracic or lumbar spine; pelvis), or T score \<-3 which justifies setting up a bisphosphonate treatment
* Affiliated to social security

Exclusion Criteria:

* Contraindication to zoledronic acid (allergy to the product, creatinine clearance \<35 ml / min, hypocalcemia, open and unhealed lesions of the soft tissues of the mouth)
* Hormone replacement therapy taken in the last 12 months
* Osteoprotective treatment (bisphosphonates, teriparatide, raloxifene, strontium ralenate or denosumab) taken in the last 12 months
* Secondary osteoporosis: hyperthyroidism, hyperparathyroidism, long-term corticosteroid therapy, hypercorticism, hypogonadism, treatment with anti aromatases / LHRH analogues, neoplastic pathology (solid or hemopathy)
* History of bilateral wrist or femur fracture
* Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
* Patient participating in another trial / having participated in another trial within 6 months

Primary outcomes:
measure: Hurst coefficient
timeFrame: Day 0
Secondary outcomes:
measure: Hurst coefficient
timeFrame: Month 12
measure: bone texture parameters
timeFrame: Day 0
measure: bone texture parameters
timeFrame: Month 12
measure: Bone mineral density
timeFrame: Day 0
measure: Bone mineral density
timeFrame: Month12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00000240: Combined Buprenorphine and Behavioral Treatment With and Without Contingent Reinforcement on Opioid and Cocaine Abstinence. - 22
Official title: Combined Buprenorphine and Behavioral Treatment Without Contingent Reinforcement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Opioid-Related Disorders
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 23
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test combined buprenorphine and behavioral treatment with and without contingent reinforcement on opioid and cocaine abstinence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Weeks abstinent
measure: Weeks continuous abstinence
measure: Overall treatment outcome
measure: Opioid dependence and psychiatric status
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104740: Dengue Seroprevalence Study in Blood Donors in the French West Indies
Official title: Dengue Seroprevalence Study in Blood Donors in the French West Indies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Donors
Dengue
Lead sponsor: Etablissement Français du Sang, Martinique
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Clinique Antilles-Guyane
First posted: 2010-04-15
Enrollment: 817
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, résidents in Martinique/ Guadeloupe (french west indies), aged 18 to 65 years coming to give their blood in one of the building or mobile collection facilities of the French Blood Establishment in French West Indies.

Brief summary: Dengue is an infectious disease most prevalent in the world. This disease is endemic in the Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a classical form with fever, and even of severe or lethal bleeding. With the possible existence of silent forms of the disease, there are no data identifying the current level of protection of the population in Martinique / Guadeloupe.

Detailed description: 1. Principal objective:

   To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood donors in the French West Indies.
2. Secondary objective:

To specify the serotypic specificity of the anti-dengue antibodies detected during the study.

Eligibility criteria: Inclusion Criteria:

* Eligible for blood donation following the French legislation,
* Resident in Martinique /Guadeloupe for at least one year
* Consent signed

Exclusion Criteria:

* Not Eligible for blood donation following the French legislation,
* Not Resident in Martinique / Guadeloupe for at least one year
* Consent not signed

Primary outcomes:
measure: Presence or not of dengue virus-specific immunoglobulin G antibodies
timeFrame: 1 day
Secondary outcomes:
measure: Characterization of dengue virus serotype-specific IgG
timeFrame: 1 day
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: French Blood Establishment of Guadeloupe
city: Fort-de-France
country: Martinique
facility: French Blood Establishment of Martinique
Study officials:
affiliation: French Blood Establishment of Martinique
name: Pascale RICHARD, MD
role: PRINCIPAL_INVESTIGATOR
References: