louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00001991: A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
Official title: A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: Trimethoprim-Sulfamethoxazole Combination
Pneumonia, Pneumocystis carinii
Antifungal Agents
Acquired Immunodeficiency Syndrome
atovaquone
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To facilitate provision of atovaquone (566C80) to patients who have mild to moderate Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole (TMP / SMX ); to monitor serious adverse events attributable to 566C80.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Clinical diagnosis of acute mild to moderate Pneumocystis carinii pneumonia.
* Dose-limiting intolerance to TMP / SMX or inadequate response to TMP / SMX.
* Willingness and ability to give informed consent. The clinical condition of the patient and appropriate physiologic criteria should be used in evaluating patients for therapy with 566C80. Patients who are rapidly progressing in disease severity or have severe disease as evidenced by sustained tachypnea (e.g., sustained respiratory rate \> 30 breaths/minute), rapid deterioration in (A-a)DO2 and chest radiograph may not be appropriate candidates for oral therapy, including 566C80. Therapy with parenteral pentamidine should be undertaken in these cases. Treatment with IV trimetrexate or primaquine / clindamycin should be considered for these patients unless the patient is known to have dose-limiting intolerance to these agents. Patients with severe PCP who are intolerant and/or unresponsive to therapy with TMP / SMX and parenteral pentamidine may enroll in the 566C80 open-label compassionate plea protocol.

Exclusion Criteria

Patients with the following prior conditions are excluded: History of serious or dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: Glaxo Wellcome Inc
state: North Carolina
Study officials:
References:
Clinical trial NCT05354791: Pre-post Spinal Popliteal Block
Official title: Comparison of Success and Injury (Neuropraxia) Rate When Performing the Sciatic Nerve Block in the Popliteal Fossa Pre vs. Post Spinal Anesthesia for Foot and Anke Procedures: Retrospective Review
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Foot Surgery
Ankle Surgery
Keywords: lower extremity peripheral nerve block
spinal anesthesia
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators plan to analyze data for patients who underwent ambulatory foot or ankle procedures with the use of spinal anesthesia and sciatic nerve block in the popliteal fossa at HSS between March 1, 2016 and February 24, 2020

Brief summary: This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.

Detailed description: This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.

Primary outcome:

- The investiigators will be looking into persistent abnormal neuropathic symptoms lasting more than 7 days following a sciatic popliteal nerve block.

Eligibility criteria: Inclusion Criteria:

* ambulatory foot surgery
* ambulatory ankle surgery
* use of spinal Anesthesia
* use of pre-spinal anesthesia nerve block techniques
* use of sciatic nerve block

Exclusion Criteria:

* all other surgeries

Primary outcomes:
measure: Persistent Abnormal Neuropathic Symptoms
timeFrame: lasting more than 7 days following a sciatic popliteal nerve block
Secondary outcomes:
measure: NRS pain scores in recovery
timeFrame: PACU recovery stay (up to 48 hours)
measure: Amount of supplemental analgesic and antiemetic provided in the PACU
timeFrame: PACU recovery stay (up to 48 hours)
measure: Anesthesia induction time
timeFrame: From the time which patients enter the OR to time of anesthesia induction end (up to 24 hours)
measure: Number of hypoxemia events during induction time
timeFrame: during induction time (up to 24 hours)
measure: Amount of sedation given
timeFrame: during induction time (up to 24 hours)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Sang Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03685994: Sleep Disorders After TIPS
Official title: The Incidence of Sleep Disorders After Transjugular Intrahepatic Portosystemic Shunt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disorder
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients who underwent TIPS in our hospital due to cirrhosis and portal hypertension.

Brief summary: The Purpose of a study to investigate the incidence of postoperative sleep disorders in patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the relationship between risk factors and prognosis of sleep disorders.


Eligibility criteria: Inclusion Criteria:

1. History of cirrhosis (clinical or by liver biopsy)
2. Portal hypertension patients with defined indications for TIPS treatment
3. Aged 18-75 years old
4. Signed written informed consent

Exclusion Criteria:

1. mental or nervous system diseases
2. Patients with alcoholic cirrhosis who are still drinking
3. Accompanied by serious heart, lung, brain and kidney diseases
4. Preoperative diagnosis of sleep disorder
5. Patients who are illiteracy
6. The total score of the preoperative Hamilton anxiety scale was greater than or equal to 14 points, and the total score of 17 points of the Hamilton depression scale was greater than or equal to 18 points

Primary outcomes:
measure: The incidence of sleep disorders after TIPS
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of hepatic encephalopathy
timeFrame: 1 year
measure: mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT05572580: Evaluation of the German Version of a Validated Keratoconus Questionaire
Official title: Evaluation of the German Version of a Validated Keratoconus Questionaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus, Unspecified, Bilateral
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited in the keratoconus outpatient clinic as part of our routine checkups

Brief summary: Keratoconus, which results in thinning of the cornea, affects mainly young patients. The causes are currently only partially known. The aim of this study is the evaluation of a keratoconus questionnaire in German. Until now this questionnaire is only in use in English.

Within the study patients will be asked to fill out a questionnaire. The questionnaire deals with issues that are influenced by keratoconus: Visual impairment and its impact on quality of life. This questionnaire (KORQ) is an already validated questionnaire in English. Within this study we would like to translate the questionnaire and validate it in German.

Within this study 50 patients will be included for the validation of the questionnaire. Based on previous studies evaluating the Keratoconus Questionnaire (KORQ) in other languages, a number of 50 patients has been shown to be sufficient for validation.

No control examination is necessary for this study.


Eligibility criteria: Inclusion Criteria:

* Keratoconus
* Signing of a written consent form for participation in the study

Exclusion Criteria:

* Difficulty in understanding patient information

Primary outcomes:
measure: Validation of Keratoconus Outcome Research Questionnaire (KORQ)
timeFrame: at screening visit
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Klinik
state: Upper Austria
Study officials:
affiliation: Kepler University Hosiptal
name: Matthias Bolz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06673680: Role Of Colposcopy In Evaluation Of Suspicious Cervix
Official title: Role Of Colposcopy In Evaluation Of Suspicious Cervix
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Cervix
Keywords: screening in cancer cervix
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Age from 30 to 64 years old.
* Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
* Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
* Women with Pap smear showing dysplasia.

Brief summary: do colposcopy and cervical punch biopsy then compare between findings

Detailed description: The aim of this study is to correlate colposcopy and histopathological findings in early screening of suspicious cervix and cervical cancer. And to do a colposcopic evaluation of all cervical lesions and the early detection of all cervical precancer and invasive lesions of the cervix in symptomatic women.

Eligibility criteria: Inclusion Criteria:

* Age from 30 to 64 years old.
* Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
* Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
* Women with Pap smear showing dysplasia

Exclusion Criteria:

* Pregnant women
* Women having active vaginal bleeding.
* Any past treatment for cervical lesions.
* Women having frank growth of cervix.
* Women who underwent a hysterectomy.

Primary outcomes:
measure: comparison between colposcopic findings of suspicious cervix and histopathologic findings
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
affiliation: Sohag university hospitals
name: Hazem A prof, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02444780: Observational Study on Plasma Glutamine Levels Before and After Cardiac Surgery
Official title: Observational Study on Plasma Glutamine Levels Before and After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glutamin Level
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients who undergo elective cardio-thoracic surgery during a 6 to 8 week period.

We aim to include at least 90 patients.

Brief summary: Earlier studies showed that a low glutamine level at acute admission on the ICU is associated with a poor outcome \[3,4\]. Recently, we found that a low plasma glutamine is correlated with severity of illness and presence of an infection after non-elective ICU admission \[5, submitted\].

Detailed description: It is known that major surgery induces a stress response characterised by hormonal release and inflammatory processes \[6,7\]. This surgical stress response resembles the catabolic stress which is found in other forms of critical illness. We did not measure plasma glutamine before surgery so it is unknown whether the plasma glutamine level was already low before surgery in these patients or that the lowering of plasma glutamine level is a consequence of surgery. Most of the patients in the elective surgery group in our study underwent cardiac surgery with use of cardiopulmonary bypass; it is known that extracorporeal circulation induces an inflammatory response but there are no clinical data on the effects on plasma glutamine or on post-operative course in relation to plasma glutamine levels \[8,9\].

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective cardiac surgery

Exclusion Criteria:

* none

Primary outcomes:
measure: plasma glutamine
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MCL
name: Hanneke Buter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buter H, Koopmans M, Kemperman R, Jekel L, Boerma C. Plasma glutamine levels before cardiac surgery are related to post-surgery infections; an observational study. J Cardiothorac Surg. 2016 Nov 25;11(1):155. doi: 10.1186/s13019-016-0549-1.
Clinical trial NCT02771080: Peak Systolic Global Longitudinal Strain and Low Cardiac Output Syndrome After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Cardiac Output Syndrome After Adult Cardiac Surgery
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 275
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: Adult patients undergoing on-pump elective or urgence cardiac surgery

Brief summary: This is a retrospective observational study to assess the relationship between peak systolic global longitudinal strain measured on pre-cardiopulmonary bypass trans-esophageal echo images predicts post-operative low cardiac output syndrome defined as the need for an inotropic support during 24 hours or longer.


Eligibility criteria: Inclusion Criteria:

* Cardiac surgery involving the use of cardiopulmonary bypass
* Availability of pre-cardiopulmonary bypass trans-oesophageal echo images allowing measurement of the peak systolic global longitudinal strain

Exclusion Criteria:

* Preoperative atrial fibrillation
* Preoperative critical state
* Emergent/salvage surgery
* Heart transplant surgery
* Left ventricular assist device implantation

Primary outcomes:
measure: Post-operative low cardiac output syndrome
timeFrame: 30 days
Secondary outcomes:
measure: Length of intensive care unit stay
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: 30-day or in hospital mortality
timeFrame: 30 days
measure: duration of post-operative mechanical ventilation
timeFrame: 30 days
measure: post-operative acute kidney injury
timeFrame: 30 days
measure: Need for readmission to the intensive care
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
citation: Amabili P, Benbouchta S, Roediger L, Senard M, Hubert MB, Donneau AF, Brichant JF, Hans GA. Low Cardiac Output Syndrome After Adult Cardiac Surgery: Predictive Value of Peak Systolic Global Longitudinal Strain. Anesth Analg. 2018 May;126(5):1476-1483. doi: 10.1213/ANE.0000000000002605.
Clinical trial NCT02518880: Dynamics of Stroke Volume and Cardiac Output During Parabolic Flight, and Its Relationship to Intravascular Volume
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To understand the cardiovascular reactions of the human body to changing conditions of gravity is an important aim of space science. In this context, cardiac output (CO) is a key value to estimate the human cardiovascular system.

The main objective of this experiment is to determine the effects of parabolic flight on intravascular volume, and how these changes modulate the complex haemodynamics induced by the parabolas.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers (men or women),
* aged from 18 to 55,
* affiliated to a Social Security system,
* who accept to take part in the study,
* who have given their written stated consent,
* who already participated in parabolic flights (even in the same campaign)
* All subjects will pass a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection

Exclusion Criteria:

* person who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
* pregnant women

Primary outcomes:
measure: haemoglobin concentration
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT01877980: Ultrasound and Pediatric Endotracheal Tube Size
Official title: Prediction of Uncuffed Endotracheal Tube Size in a Pediatric Population by Sonographic Measurements at Various Structures of the Airway Compared to Age-related Formulas and Little-finger Diameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation With Uncuffed Endotracheal Tube
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 101
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children scheduled for elective surgery

Brief summary: The aim of the present study was to evaluate the ultrasonographic airway measurement in pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse airway diameter (MTAD) with tube size predicted by different age-related formulas and diameter of little finger.

Previous studies already showed that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTAD. In this study measurements are performed at three predefined anatomic structures of the airway with each of These at two airway pressures.

The investigators hypothesize that one of the specific measurements predicts the fitting ETT size better than age-related formulas or diameter of little finger.


Eligibility criteria: Inclusion Criteria:

* signed informed consent by the legal guadian
* elective surgery requiring endotracheal intubation

Exclusion Criteria:

* missing informed consent
* allergy to ultrasound gel

Primary outcomes:
measure: Minimal transverse airway Diameter (MTAD)
timeFrame: Between administration of muscle relaxant and intubation (3min)
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT04667962: Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain
Official title: Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout, Caregiver
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of caregivers from the French Armed Forces Health Service (Medical doctor, nurse, assistant nurse, ...) who have been in employment when the COVID-19 health crisis began in France.

Brief summary: The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers.

The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.


Eligibility criteria: Inclusion Criteria:

* To be caregivers
* Have been in employment between March 15 and May 15, 2020

Exclusion Criteria:

* None

Primary outcomes:
measure: Burn-out Assessment tool (BAT) score at enrollment.
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
city: Paris
country: France
facility: Ecole du Val-de-Grâce
Study officials:
References: