louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01029496: Immediate VS Delayed Cord Clamping on Newborns
Official title: Effect of Umbilical Cord Clamping Time on Newborns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Newborn
Umbilical Cord
Keywords: umbilical CORD CLAMPING
Neonatal anemia
Omphalitis
Lead sponsor: Hainan Medical College
Sponsor class: OTHER
First posted: 2009-12-10
Enrollment: 120
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The best time of the umbilical cord clamping has not been fully understood. immediate cord clamping (with in 10 seconds after birth) has been standardized practice for many years, while WHO protocol recommends to wait for 60-90 seconds. but the umbilical cord may still pulse for more than 90 seconds. is it best to wait longer until the pulsing ceased? how the time of umbilical cord will affect the newborn? will the longer time be less umbilical bleeding and shorter departure time of the cord? the hypothesis of this study is: to cut the cord after the pulsing ceased is the best time for cord clamping and will result in better quality of life for the newborn and less cord bleeding and earlier departure time of the cord, that means less infections of the cord.

Detailed description: 1. for normal newborn (apgar score over 7), regardless term or preterm,normal birth or cesarean section born: experimental group1: waiting for the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen.

   control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth.
2. for in case of newborn asphyxia(regardless term or preterm,normal birth or cesarean section born):

experimental group2: resuscitate on bed site with the cord unclamped until the umbilical cord ceased pulsing.

control group 2-1 clamping and cut the cord within 10 second. and resuscitate the baby after transfer to the Irradiation table.

Eligibility criteria: Inclusion Criteria:

* all living baby after birth, including term, preterm, normal birth, cesarean section, apgar score over 7 or less than that.

Exclusion Criteria:

* still birth

Primary outcomes:
measure: hemoglobin level of the baby 1 month after birth
timeFrame: 2 years
Secondary outcomes:
measure: departure time of the umbilical cord
timeFrame: 2 years
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Medical College Appendix Hospital
state: Hainan
Study officials:
affiliation: director of ob&gny dpt.of appendix hospital of hainan medical college
name: hua shao ping, professor
role: STUDY_DIRECTOR
References:
citation: zhang hong-yu,Meng li-ping,Xie chun-li.summary of current clinical protocols of umbilical cord care.Chinese journal of nurisng.3(43):275-277,2008
Clinical trial NCT05875896: Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate
Official title: Investigation of the Functional Status After Wrist Arthrodesis (Medartis Aptus Model) in Patients With Rheumatoid Arthritis Compared to Patients With Post-traumatic Wrist Destruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wrist Arthritis
Wrist Osteoarthritis
Keywords: Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis
Lead sponsor: Waldfriede Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have either suffered wrist destruction due to rheumatiod arthritis inflammation, or individuals who have received wrist fusion due to post-traumatic osteoarthritis.

Brief summary: The primary working hypothesis of this study is whether wrist arthrodesis leads to an improvement in functional status in both rheumatoid arthritis and post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18-90
* Wrist fusion took place between 2014 and 2022 using Aptus 2.5 TriLock Total Wrist Fusion Plate, Medartis at Hospital Waldfriede
* rheumatoid Arthritis
* post-traumatic osteoarthritis patterns: 1. scapholunate advanced collapse (SLAC) or 2. scaphoid nonunion advanced collapse (SNAC)

Exclusion Criteria:

* post surgery bone fracture of the same limb
* Pregnancy, lactation
* active malignant tumor

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
timeFrame: all patients who underwent surgery between 2014 to 2022
Secondary outcomes:
measure: Postoperative complications
timeFrame: all patients who underwent surgery between 2014 to 2022
measure: Function
timeFrame: all patients who underwent surgery between 2014 to 2022
measure: Functional assessment: Goniometry
timeFrame: all patients who underwent surgery between 2014 to 2022
measure: Visual analogue scale (VAS) Pain
timeFrame: all patients who underwent surgery between 2014 to 2022
measure: Short-Form 36 (SF-36)
timeFrame: all patients who underwent surgery between 2014 to 2022
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Waldfriede Hospital
Study officials:
affiliation: Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
name: Lautenbach Martin, MD
role: STUDY_CHAIR
affiliation: Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
name: Markus Bock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00493896: Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients
Official title: Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Venous Thromboembolism Prophylaxis
VTE prophylaxis
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-06-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.

Detailed description: This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, \& platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr \< 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary \& secondary diagnoses, central venous access, and sequential compression device utilization.

Eligibility criteria: Inclusion Criteria:

1. Ability or legally authorized representative (LAR) to provide informed consent
2. Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.

Exclusion Criteria:

1. Active or suspected bleeding
2. Platelet count less than 100,000 per microliter (mm3) of blood
3. Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
4. Initial estimated CLcr \< 30 ml/min as determined by the Cockcroft-Gault equation
5. Initial labs indicative or suggestive of rapidly rising serum Creatinine (\>1 mg/dL/day)
6. Pregnancy (for medicolegal considerations)
7. Patients with or expecting to require an epidural catheter
8. Patients who are expected to have an immediate (within 24h) need for surgery

Primary outcomes:
measure: Bleeding events
timeFrame: inpatient hospitalization
Secondary outcomes:
measure: Development of thrombocytopenia
timeFrame: inpatient hospitalization
Other outcomes:
Locations:
Study officials:
affiliation: Eastern VA Medical School, Norfolk, VA
name: Charles W Callender, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02992496: Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
Official title: Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Major Depressive Episode
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
* Hamilton depression rating scale score ≥ 19
* Willingness and competence to sign the informed consent form
* Stable psychopharmacological treatment for 10 days (except benzodiazepines)

Exclusion Criteria:

* Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion
* Prior use of ketamine
* Pregnancy/Breast feeding
* Instable arterial hypertension \>170/110mmHg
* Hepatic dysfunction
* Hyperthyreosis
* History of glaucoma
* Neurodegenerative disorders
* Any unstable medical illness
* History of substance abuse within the past 12 months
* History of psychosis
* Failure to comply with the study protocol or to follow the instructions of the investigating team
* Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 1 week
Secondary outcomes:
measure: Clinician Administered Dissociative States Scale (CADSS)
timeFrame: 2 weeks
measure: Hamilton Depression Rating Scale
timeFrame: 1 week
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Psychiatry and Psychotherapy, Medical University of Vienna
Study officials:
References:
Clinical trial NCT03971396: The Chest Physiotherapy and Breathing Exercises Management of Patients Following Open Heart Surgery: a National Survey of Practice in Turkey.
Official title: The Chest Physiotherapy and Breathing Exercises Management of Patients Following Open Heart Surgery: a National Survey of Practice in Turkey.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Physiotherapy
Keywords: open cardiac surgery
breathing exercises
chest physiotherapy
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Koşuyolu Kartal Heart Training and Research Hospital
First posted: 2019-06-03
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physiotherapists working in cardiovascular intensive care

Brief summary: Chest physiotherapy and breathing exercises are an important non-pharmacological treatment modality in order to prevent and minimize postoperative respiratory complications in patients undergoing open heart surgery. Different respiratory techniques are used after cardiac surgery, but there is no opinion about which technique or exercise is effective. The purpose of this study, practical application of chest physiotherapy to patients who have had open heart surgery in Turkey and to identify methods of breathing exercises.

Detailed description: In this study, cardiovascular surgery in Turkey to employees or physiotherapist who worked in intensive care units was planned as e-mail or by reaching to answer the survey questions via telephone.

The universe of study in Turkey cardiovascular surgery physiotherapists are all actively working or have worked in intensive care.

Eligibility criteria: Inclusion Criteria:

* To worked or still working in cardiovascular surgery intensive care units
* To answer the survey questions

Exclusion Criteria:

* To Working or worked in cardiovascular surgery intensive care unit and but not answering questionnaire questions

Primary outcomes:
measure: Delivery of surveys
timeFrame: 1 month
measure: Evaluation of survey results
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
Study officials:
name: Halime Sinem Barutçu
role: PRINCIPAL_INVESTIGATOR
name: Hatun İlkatmış İnce
role: PRINCIPAL_INVESTIGATOR
name: Füsun Güzelmeriç
role: STUDY_DIRECTOR
References:
citation: Westerdahl E, Olsen MF. Chest physiotherapy and breathing exercises for cardiac surgery patients in Sweden--a national survey of practice. Monaldi Arch Chest Dis. 2011 Jun;75(2):112-9. doi: 10.4081/monaldi.2011.223.
citation: Reeve J, Denehy L, Stiller K. The physiotherapy management of patients undergoing thoracic surgery: a survey of current practice in Australia and New Zealand. Physiother Res Int. 2007 Jun;12(2):59-71. doi: 10.1002/pri.354.
Clinical trial NCT01272596: Evaluation of Sloan-Charts for Assessment of Disease Progress in Multiple Sclerosis
Official title: Evaluation of Low Contrast Sloan Visual Charts as Method for the Assessment of Disease Progression in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Visual Contrast Acuity
Visual Contrast Sensitivity
Sloan Charts
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Novartis Germany GmbH
First posted: 2011-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Clinically Isolated Syndrome or Definite Multiple Sclerosis

Brief summary: Impairment of visual deficits, in particular contrast acuity and contrast impairment are frequent symptoms in MS. However, visual function is not appropriately covered by the standard tools for clinical assessment, namely, the EDSS and the MSFC.

The primary aim of this study is to investigate, whether in MS patients contrast acuity and sensitivity change over a period of two years.

Secondary aims are the correlation of visual contrast parameters with structural retinal changes and quality of life.


Eligibility criteria: Inclusion Criteria:

* Clinically Isolated Syndrome or definite MS (relapsing-remitting or secondary progressive course)
* Written Informed Consent

Exclusion Criteria:

* Relapse within the last 30 Days
* Significant Cognitive Impairment
* Severely Decreased Visual Acuity
* Preexisting Severe Retinal Pathology

Primary outcomes:
measure: Visual Contrast Acuity
timeFrame: 24 Months
Secondary outcomes:
measure: Structural and Functional Changes of Optic Pathway
timeFrame: 24 Months
measure: Clinical Neurological Assessment
timeFrame: 24 Months
measure: Quality of Life
timeFrame: 24 Months
measure: Contrast Sensitivity
timeFrame: 24 Months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Study officials:
affiliation: NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
name: Jan M Dörr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04211896: Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer
Official title: The Efficacy and Safety of Anlotinib Combined With Nivolumab as a Second-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 70
Sex: ALL
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: TREATMENT

Brief summary: This study evaluates the safety and efficacy of anlotinib in combination with nivilumab as second-line treatment in advanced NSCLC patients. The primary endpoint of the study is progression-free survival (PFS);the secondary endpoints are disease control rate (DCR), objective response rate (ORR), overall survival (OS) and safety.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged 18-75 years old;
2. ECOG PS：0-1,Expected Survival Time: Over 3 months;
3. Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC, with measurable nidus(using RECIST 1.1);
4. For local advanced or advanced NSCLC, disease progression occurred after first-line systemic treatment previously;
5. The negative patients in EGFR\&ALK can participate or who positive in EGFR\&ALK, have or have not drug tolerance after the treatment with relative targeted drugs;
6. main organs function is normal;
7. Signed and dated informed consent.

Exclusion Criteria:

1. have used Anlotinib before;
2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer);
3. examined as positive in EGFR\&ALK mutation detection and never take the treatment of TKIs;
4. Previously (within 5 years) or presently suffering from other malignancies;
5. Symptomatic or uncontrolled brain metastases;
6. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
7. Pregnancy or lactation.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 6 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
measure: Disease control rate (DCR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
measure: Overall Survival (OS)
timeFrame: 12 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Until 30 day safety follow-up visit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01379716: Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia and Healthy Controls
Official title: Immunolabeling Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia (PHN) and Age and Gender-Matched Normal Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postherpetic Neuralgia
Healthy Age/Gender Matched Volunteers
Lead sponsor: Albany Medical College
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-06-23
Enrollment: 10
Sex: MALE
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Postherpetic Neuralgia is a painful nerve condition that can occur when nerve fibers are damaged following an outbreak of shingles.

The purpose of this study is to identify and study abnormalities in the nerves and cells in the of patients with postherpetic Neuralgia (PHN) and characterize changes that could be responsible for causing nerve pain. This data will be compared to the tissue of healthy volunteers. Our goal is that this information will lead to the development of better treatment options for people with painful nerve conditions.


Eligibility criteria: Inclusion Criteria:

Group 1: 5 Caucasian males \>50 years of age with PHN of greater than 6 months duration since rash healed and clinically meaningful pain (Visual Analog Scale (VAS) \>40mm at Baseline) Group 2: 5 Caucasian males \>50 years of age, non-diabetic with no nervous system disease (healthy control groups)

Exclusion Criteria:

1. History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator
2. Allergy to lidocaine
3. Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
4. History of slow-healing diabetic foot ulcers
5. HgA1c \>11% within the last three months
6. Active cancer within the previous two years, except treated basal cell carcinoma of the skin
7. Co-morbidities that can produce neuropathy
8. Subjects taking sodium channel blockers within one week of study treatment and throughout the study
9. Subjects taking any other experimental drugs within 30 days prior to enrollment
10. Application of lidocaine patch to either foot or to PHN site within two weeks of enrollment

Primary outcomes:
measure: use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
affiliation: Albany Medical College
name: James P. Wymer, MD
role: PRINCIPAL_INVESTIGATOR
References: