louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01283451: Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity
Official title: Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Compartment Syndrome
Keywords: near-infrared spectroscopy
Lead sponsor: J&M Shuler
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample will consist of healthy volunteers recruited from the principle investigator's private practice.

Brief summary: Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS). Placement of these sensor pads on the surface of the skin must be such that light penetrates the intended compartment without inadvertently obtaining measurements of an adjacent compartment. The objective of this study is to examine whether the NIRS measurements of each compartment truly represent the tissue perfusion of the intended compartment, as indicated by the predictable decrease in muscle oxygenation of a given compartment in response to muscle fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated compartment will significantly decrease following muscle stimulation, indicating that the intended muscle compartment was successfully isolated. Additionally, the investigators hypothesize that NIRS values of unstimulated muscle compartments will not change from baseline.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* no current extremity injuries
* willing to provide written informed consent

Exclusion Criteria:

* history of any anatomy-altering surgery to the extremity in question
* history of peripheral vascular disease
* history of pulmonary disease

Primary outcomes:
measure: Near infrared spectroscopy
timeFrame: <30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Orthopedic Clinic, PA
state: Georgia
Study officials:
affiliation: Athens Orthopedic Clinic, PA
name: Michael Shuler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05050851: Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt
Official title: Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoalbuminemia
Stunted Growth
Anemia, Iron Deficiency
Keywords: Pneumonia, nutrition, blood tests, body mass index
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children admitted at Assiut university children hospital below five years with diagnosis of pneumonia on admission.

Brief summary: Decrease mortality rate resulting from pneumonia

Detailed description: Recruiting patients with pneumonia admitted at Assiut University hospital . Then assessment of their condition and severity of pneumonia by examination and X-ray chest . After that, we aim at assessment their nutrition status and it's effect on severity of pneumonia. So we aim to investigate them by CBC, Albumin, CRP and CXR and correlate these parameters with the severity of pneumonia to assess the impact of nutrition on outcome of chest infections

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pneumonia on day 1 of hospital admission.

Exclusion Criteria:

* patients with cardiac diseases
* patients with immune deficiency disorders

Primary outcomes:
measure: ratio of body mass index in patients with pneumonia
timeFrame: Day 1 assessment on hospital admission
Secondary outcomes:
measure: Concentration of Albumin in patients with pneumonia in g/dl
timeFrame: Day 1 assessment on hospital admission
measure: Hemoglobin level in patients with pnemonia in g/dl
timeFrame: Day 1 assessment on hospital admission
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06239051: Greening the Humanitas Fertility Center: How to Build a More Sustainable Medical Daily Routine
Official title: Humanitas Fertility Center: The Green (R)Evolution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sustainability
Female Infertility
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All outpatient, surgical and laboratory procedures, considered as daily clinical routine at the Humanitas Fertility center, will be taken into account, analysed and defined as appropriate or not.

Brief summary: The goal of this observational study is to redefine an everyday clinical routine at the Humanitas Fertility center calculating the effects derived from the reduction of inappropriate and avoidable tests, procedures, tools and treatments currently used.

Anonymized patients data about clinical procedures are used, taken from the internal database of the Humanitas fertility center


Eligibility criteria: All outpatient, surgical and laboratory procedures, considered as daily clinical routine at the Humanitas Fertility center, will be taken into account, analysed and defined as appropriate or not.

Primary outcomes:
measure: Reduction of avoidable procedures and assessment of its enviromental impact
timeFrame: From 18th September 2023 to 24th September 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Michele Tedeschi
role: STUDY_CHAIR
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Paolo Emanuele Levi Setti
role: STUDY_DIRECTOR
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Camilla Ronchetti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01322451: Oral Bioavailability of Two Solid Formulations of GLPG0259.
Official title: A Randomized, Open Label, 2-way Crossover Study to Compare the Oral Bioavailability of 2 Solid Dose Formulations of GLPG0259 After Single-dose Intake in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2011-03-24
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Bioavailability of two solid dosage formulations of GLPG0259
timeFrame: up to 96 hours postdose
Secondary outcomes:
measure: Safety and tolerability of GLPG0259
timeFrame: up to 96 hours postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Johan Beetens, PharmD, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Lien Gheyle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02116751: Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients
Official title: Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients: Role of Classical Factors, HIV Infection, and Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Toxicity
Keywords: HIV, antiretroviral, toxicity, eGFR, tubular disease, BMD
Lead sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor class: NETWORK
First posted: 2014-04-17
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected patients in active follow up, receiving antiretroviral therapy

Brief summary: The purpose of this study is to determine the frequency of renal and bone toxicity in HIV infected patients receiving antiretroviral therapy, and the outcome in terms of treatment change or/and virological failure, in relation with the presence of classical factors, such as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and the effects of antiretroviral medication.

Detailed description: This is a retrospective cohort study involving 300 patients to determine the frequency of renal and bone comorbidities/toxicity in a large population of HIV-infected patients receiving antiretroviral therapy, in order to establish the differential role of classical factors, HIV infection, or antiretroviral therapy.

Eligibility criteria: Inclusion Criteria:

* Confirmed HIV infection

Exclusion Criteria:

* Pregnancy
* Prior therapy with antineoplastic chemotherapy or chronic treatment with corticosteroids
* Previous chronic therapy with antiresorptive bone therapy

Primary outcomes:
measure: Incidence of Renal and Bone toxicity
timeFrame: Patients will be evaluated for 2 years before
Secondary outcomes:
measure: Consequences of renal or bone toxicity
timeFrame: Patients will be evaluated for 2 years before
Other outcomes:
measure: Changes in renal and bone toxicity
timeFrame: 2 years before entry
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
Study officials:
affiliation: Ramon y Cajal Hospital
name: Jose L Casado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236651: Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Official title: Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Detailed description: Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Protocol of Thesis Submitted for partial fulfillment of master degree in Obstetrics \& Gynecology

The aim of this work is to compare and to evaluate the efficacy of drotaverine hydrochloride versus meperidine hydrochloride on the duration of the 1st stage of labor.

Eligibility criteria: Inclusion Criteria: ● primigravida.

* Singleton pregnancy.
* Term gestation i.e, 38-41 weeks.
* Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.
* Vertex presentation with occipito anterior position.
* Efficient uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.

Exclusion Criteria: ● Abnormal presentation or occipito posterior position.

* Multiple pregnancies.
* Cephalo-pelvic disproportion.
* Cervical surgery in the past or history of cervical injury.
* Patients on antihypertensive therapy.
* Known hypersensitivity to drotaverine or meperidine.
* If any other spasmolytic agent had been used within 48 hours.

Primary outcomes:
measure: the duration of the first stage of labor
timeFrame: 6 monthes
measure: effect on the duration of the 1st stage of labor
timeFrame: 6 monthes
Secondary outcomes:
measure: effect on pain
timeFrame: 6 monthes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mahmoud
Study officials:
References:
Clinical trial NCT02131051: Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis
Official title: Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray and Eye Drops in Patients With Allergic Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinoconjunctivitis
Keywords: ectoine
allergic rhinitis
bitop
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes Azelastine nasals spray and eye drops according to the instructions for use. The observation takes place over a period of 7 days. Response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.


Eligibility criteria: Inclusion Criteria:

* male or female patients
* aged 18-70 years
* Patients with proven allergy and acute symptoms in nose and eye which are treated with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray and Azelastine Eye Drops during the observational period

Exclusion Criteria:

* pregnancy and nursing women,
* drug addicts and persons unable to give consent to study participation,
* patients with intolerance against ingredients of any of the study treatments,
* previous eye or nose surgery,
* concomitant treatment with anti-allergic drugs, and
* diseases which might influence the output of the study according to the physicians' judgment.
* contra indications according to the label

Primary outcomes:
measure: Change in primary allergic symptoms symptoms
timeFrame: Day1, Day 7
Secondary outcomes:
measure: Palatal itching score
timeFrame: day 1 and day 7
measure: Efficacy and tolerability assessment by the patients
timeFrame: day1 and day 7
Other outcomes:
Locations:
city: Elmshorn
country: Germany
facility: HNO Praxis Elmshorn
Study officials:
affiliation: HNO Praxis Elmshorn
name: Uwe Sonnemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00149851: A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)
Official title: A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Symptomatic Gastroespohageal Reflux Disease
Keywords: GERD, heartburn, regurgitation, reflux disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 832
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid regurgitation This study will determine if Tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of heartburn.


Eligibility criteria: Inclusion Criteria:

* History of physician diagnosed GERD
* Heartburn and Regurgitation 3 Days during the week prior to screening

Exclusion Criteria:

* History of erosive esophagitis, Barrett's esophagus, esophageal stricture, scleroderma, Zollinger-Ellison Syndrome, known primary disorder
* History or presence of infection or inflammation of the small or large intestine, gastrointestinal malignancy, history of upper GI surgery
* Use of PPI during the last four weeks prior to screening

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Proportion of patients experiencing resolution of heart-burn during week 4 of treatment
measure: Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone
measure: Decreasing frequency of regurgitation during week 4 of treatment
measure: Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT03428451: Prophylaxis Versus Treatment for TURP Syndrome.
Official title: Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transurethral Resection of Prostate Syndrome
Keywords: TURP
hypertonic saline
TURP syndrome
hyponatraemia
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to investigate the usage \& effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications

Detailed description: The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs \[mean BP, HR, CVP \& oxygen saturation (spO2)\] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.

Eligibility criteria: Inclusion Criteria:

* ASA class I - III BPH patients

Exclusion Criteria:

* Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation.
* Electrolyte imbalance,
* Uncontrolled hypertension,
* Congestive heart failure or being allergic to local anesthetics.

Primary outcomes:
measure: Serum sodium level measured in mEq/L
timeFrame: 72 hours
Secondary outcomes:
measure: Incidence of TURP syndrome
timeFrame: 72 hours
measure: Need for ICU admission
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Faculty of medicine- Cairo University- Egypt
name: Ahmed ELbadawy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00997451: Fatigue Self-Management in Primary Care
Official title: Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medically Unexplained Chronic Fatigue
Chronic Fatigue Syndrome
Keywords: Medically unexplained chronic fatigue
Chronic fatigue syndrome
Cognitive-behavior therapy
Self-management
Primary care
Nurses
Economic analysis
Cost effectiveness
One year follow-up
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.


Eligibility criteria: Inclusion Criteria:

* diagnosis of unexplained chronic fatigue
* diagnosis of chronic fatigue syndrome

Exclusion Criteria:

* medically explained fatigue
* any psychosis or dementia

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 3 months, 6 months, 15 months
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: 3 months, 6 months, 15 months
measure: Beck Depression Inventory
timeFrame: 3 months, 6 months, 15 months
measure: SF-36 physical function subscale
timeFrame: 3 months, 6 months, 15 months
measure: Global Impression of Change Rating
timeFrame: 3 months, 6 months, 15 months
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Fred Friedberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meng H, Friedberg F, Castora-Binkley M. Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial. BMC Fam Pract. 2014 Nov 25;15:184. doi: 10.1186/s12875-014-0184-7.
citation: Friedberg F, Napoli A, Coronel J, Adamowicz J, Seva V, Caikauskaite I, Ngan MC, Chang J, Meng H. Chronic fatigue self-management in primary care: a randomized trial. Psychosom Med. 2013 Sep;75(7):650-7. doi: 10.1097/PSY.0b013e31829dbed4. Epub 2013 Aug 6.