louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02137915: Long-Term Follow-up Safety Study of Human Central Nervous System Stem Cells in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
Official title: Long-Term Follow-up Study of the Phase I/II Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Age-Related Macular Degeneration
Geographic Atrophy
Keywords: AMD
Lead sponsor: StemCells, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 8
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects with age-related macular degeneration (AMD) with GA who received transplantation of HuCNS-SC in Study CL-N01-AMD.

Brief summary: This study is being done to determine the long-term safety and possible benefits of transplanted Human Central Nervous System Stem Cells (HuCNS-SC) for patients with Geographic Atrophy of Age-Related Macular Degeneration. This long-term follow-up study is limited to those individuals who received a transplant of HuCNS-SC cells into one of their eyes as part of the CL-N01-AMD study. No additional study product will be given in this 4-year long-term follow-up study.


Eligibility criteria: Inclusion Criteria:

* Must have completed Study CL-N01-AMD
* Must be able to provide written informed consent prior to any study related procedures
* Agree to comply in good faith with all conditions of the study and to attend all required study visits

Exclusion Criteria:

* Inability to comply with study procedures or visits
* Since enrolling in Study CL-N01-AMD, have entered, or are about to enter another investigational study that, in the opinion of the Principal Investigator (PI), might confound study interpretation.
* Received off-study immunosuppressive agents in the lead-in study or are receiving any immunosuppressive agents since completing the lead-in study

Primary outcomes:
measure: Frequency and types of serious adverse events
timeFrame: At each of 11 visits over a period of 48 months
Secondary outcomes:
measure: Frequency and types of adverse events
timeFrame: At each of 11 visits over a period of 48 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
affiliation: Principal Investigator
name: David Birch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06498115: Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia
Official title: Effect of Prophylactic Intravenous Norepinephrine Infusion on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia for Caesarean Section
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Maternal Hypotension
Keywords: norepinephrine
maternal hypotension
Lead sponsor: The Third People's Hospital of Bengbu
Sponsor class: OTHER_GOV
First posted: 2024-07-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Norepinephrine has emerged as a potential alternative for stabilizing blood pressure during spinal anesthesia for cesarean section, purportedly maintaining maternal heart rate and cardiac output more effectively than phenylephrine. However, its application as an intravenous bolus for treating hypotension remains underexplored. Consequently, this current investigation aimed to determine the ED50 and ED95 of norepinephrine for managing maternal hypotension during cesarean section. A prospective trial enrolled 100 patients undergoing elective delivery under spinal anesthesia, with norepinephrine dosage determined using the upper and lower sequential distribution method (UDM).


Eligibility criteria: Inclusion Criteria:

Inclusion criteria included women undergoing elective caesarean section undergoing combined lumbar and rigid anaesthesia, healthy singleton pregnancies at full term (more than 37 weeks gestation), American Society of Anaesthesiologists physical status I or II, body weight between 50-100 kg, height between 150-180 cm, and fasting for more than 8 hours.

Exclusion Criteria:

The exclusion criteria included individuals with hypertension, cardiovascular diseases, preeclampsia, arrhythmias, diabetes mellitus, spinal cord malformations, abnormal fetal conditions, and those who declined to participate in the study.

Primary outcomes:
measure: Intravenous norepinephrine to maintain maternal systolic blood pressure 80% above baseline before fetal delivery.
timeFrame: From the initiation of anesthesia to the delivery of the fetus.
Secondary outcomes:
measure: Intraoperative adverse reactions
timeFrame: Perioperative period
measure: Number of remedial drugs
timeFrame: Perioperative period
measure: Neonatal Apgar score
timeFrame: Immediately After delivery of the foetus
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The Third People's Hospital of Bengbu
state: Anhui
Study officials:
affiliation: The Third People's Hospital of Bengbu
name: Liang Cheng
role: STUDY_DIRECTOR
References:
Clinical trial NCT03040115: Assessment of Safety of Air Travel in Patients With Birt-Hogg-Dube Syndrome
Official title: Assessment of Safety of Air Travel in Patients With Birt-Hogg-Dube Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birt-Hogg-Dube Syndrome
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Rare Diseases Clinical Research Network
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-02-02
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a confirmed diagnosis of Birt-Hogg-Dube syndrome are eligible to participate in this study.

Brief summary: The aim of this study is to conduct survey-based assessments for the safety of air travel in patients with Birt-Hogg-Dube syndrome (BHD). The study will enroll patients through the clinic network at Rare Lung Disease Consortium (RLDC) and through the BHD foundation website. Patients will have access to the questionnaire via REDCap (an online data management system) and each patient will be provided with a link to complete the survey. The investigators plan on enrolling approximately 100 patients with BHD for the purpose of this study. Secondary aims of this study include further characterization of the clinical aspects of disease and to establish a contact registry for these patients, in order to facilitate future studies.


Eligibility criteria: Inclusion Criteria:

* Adult, age 18 or older
* English literate
* Signed, dated informed consent; either given electronically or via paper form
* Diagnosis of BHD confirmed by either a) the presence of fibrofolliculomas/trichodiscomas on skin biopsy, or b) the presence of pathogenic FLCN mutations.

Exclusion Criteria:

* Inability to give informed consent

Primary outcomes:
measure: Number of Patients With Birt-Hogg-Dube Syndrome Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel
timeFrame: During air travel or within 24 hours following air travel
Secondary outcomes:
measure: Number of Patients With Birt-Hogg-Dube Syndrome Who Experience a Spontaneous Pneumothorax
timeFrame: 3 years
measure: Number of Patients With Birt-Hogg-Dube Syndrome Who Experience Recurrent Pneumothorax Following Pleurodesis
timeFrame: 3 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Nishant Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948415: Evaluation of the Shape Up Rhode Island Campaign Study 5
Official title: Evaluation of the Shape Up Rhode Island Campaign Study 5: Does Adding Behavioral Weight Control Information to Shape-Up Rhode Island Improve Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
Internet
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Obesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI). The current trial is investigating whether adding both a behavioral intervention delivered online PLUS automated feedback to self-monitoring would enhance the outcomes of SURI participants.

Detailed description: Background: Given the epidemic of obesity, approaches to weight loss that can be applied on a community, state, or national level are needed. This project is an ongoing evaluation of Shape Up Rhode Island (SURI) program, a state-wide Internet based program involving team-based competition to increase physical activity and achieve weight loss.

Aim: To enhance the effectiveness of SURI utilizing a minimal contact intervention delivered online.

Design: SURI 2009 participants were invited to join a research study focusing on weight loss. Interested participants were randomized to two groups including a SURI Enhanced group (behavioral intervention presented in 12 weekly online presentations, daily self-monitoring, and weekly automated feedback) or a SURI Standard group (group given a list of previously existing online resources to aid with weight loss).

Eligibility criteria: Inclusion Criteria:

* Overweight or obese
* Current participant in the Shape Up RI program weight loss competition

Exclusion Criteria:

* None

Primary outcomes:
measure: Weight loss at the end of Shape Up RI
timeFrame: 3 Months
Secondary outcomes:
measure: Weight loss maintenance 6 months after program completion
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT00463515: Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC
Official title: A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-resectable Stage III Non-Small-Cell-Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell-Lung Cancer
Keywords: Non-Small Cell Lung Cancer
NSCLC
Chemoradiation
lung cancer
induction chemotherapy
chemo-radiotherapy
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: Eli Lilly and Company
First posted: 2007-04-20
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. The induction chemotherapy is then to be followed by chemo-radiotherapy.


Eligibility criteria: Inclusion Criteria:

* cytological or histologically proven NSCLC
* unresectable stage III NSCLC
* presence of at least one measurable lesion (RECIST criteria)
* adequate haematological, renal and hepatic function
* adequate lung function reserve
* good condition, weight loss \<10% over previous 6 months, life expectancy \> 3 months

Exclusion Criteria:

* previous chemotherapy for NSCLC
* distant metastasis or a pleural or pericardial effusion
* treatment for malignant disease in the past or serious concomitant medical or psychiatric disease
* active uncontrolled infection at time of inclusion
* interstitial lung disease
* auto-immune systemic disease with potential involvement of the lungs
* concomitant use of amiodarone

Primary outcomes:
measure: 2-year survival rates
Secondary outcomes:
measure: Response rate
measure: Time to intrathoracic failure
measure: Overall survival
measure: Toxicity of induction chemotherapy
measure: Toxicity of chemo-radiotherapy
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
state: Antwerp
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Wilrijk
country: Belgium
facility: Sint Augustinus Ziekenhuis
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Paul R Germonpre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00389415: Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes
Official title: A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin (100 mg qd) In Patients With Type 2 Diabetes (Extension Study of Study CLAF237A1303)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Vildagliptin
HbA1c
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.


Eligibility criteria: Inclusion Criteria:

* Diagnosis as Type 2 Diabetes
* Patients who have completed study CLAF237A1303
* Outpatients

Exclusion Criteria:

* Patients who prematurely discontinued Study CLAF237A1303
* Other protocol-defined inclusion/exclusioncriterial may apply

Primary outcomes:
measure: Adverse events profile after 52 weeks of treatment
Secondary outcomes:
measure: Change from baseline to endpoint on HbA1c at 52 weeks
measure: Change from baseline to endpoint on fasting plasma glucose at 52 weeks
measure: Change from baseline to endpoint in HOMA B at 52 weeks
measure: Change from baseline to endpoint in HOMA IR at 52 weeks
measure: Change from baseline to endpoint in body weight at 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04670315: Validation of the Telematic Version of the Fugl-Meyer Scale
Official title: Validation of theTelematic Spanish Version of the Fugl-Meyer Assessment of Motor Recovery After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Validation Study
Patient Outcome Assessment
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years with a diagnosis of stroke

Brief summary: Stroke is one of the most prevalent pathologies worldwide and its consequences require long-term treatment. The current situation caused by the Sars-cov-2 virus has collapsed health systems and has delayed these patient's treatment. The proposed alternative is telerehabilitation: a treatment system that has already proved its effectiveness. However, the difficulty to assess the stroke patient's functional status is the great problem. For this reason, a Fugl Meyer Assessment Scale adaptation, one of the most widely used (in research and in clinic), is proposed to be carried out remotely. The objective of our study is to validate this scale in stroke patients.


Eligibility criteria: Inclusion Criteria:

* Being older than 18-years-old
* Diagnosis of stroke

Exclusion Criteria:

* Another neurological or orthopedic problem different than stroke that will affect functionality and balance

Primary outcomes:
measure: Fugl Meyer Assessment of sensorimotor function
timeFrame: baseline
measure: Fugl-Meyer Assessment Upper Extremity (FMA-UE)
timeFrame: Baseline
measure: Fugl-Meyer Assessment Lower Extremity (FMA-LE)
timeFrame: Baseline
measure: Fugl Meyer Assessment of sensorimotor function (Short Form)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
References:
Clinical trial NCT00553215: Quality of Life in Patients With Bladder Cancer
Official title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [QOL]
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: transitional cell carcinoma of the bladder
stage 0 bladder cancer
stage I bladder cancer
stage II bladder cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-04
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying quality of life in patients with bladder cancer may help determine the long-term effects of bladder cancer and may help improve the quality of life for patients in the future.

PURPOSE: This clinical trial is studying quality of life in patients with bladder cancer.

Detailed description: OBJECTIVES:

* To study the effects of recurrence and progression on health-related quality of life (HRQL).
* To study the effects of repeat cystoscopy on HRQL.
* To study the patients' assessments of a hypothetical prognostic model and how this affects their preference for the mode of surveillance.

OUTLINE: This is a multicenter study.

Quality-of-life questionnaires developed by the European Organization for Research and Treatment for Cancer (EORTC) will be used. The EORTC QLQ-BLS24 with 24 questions specific to non-muscle-invasive bladder cancer and the EORTC QLQ-BLM30 with 30 questions specific to muscle-invasive bladder cancer will be combined and used in conjunction with the general cancer questionnaire QLQ-C30.

Assessments using the QLQ-C30 will be made at baseline in the entire cohort of patients. Follow-up assessments using the QLQ-C30, QLQ-BLS24, and QLQ-BLM30 167 will be made at first routine follow-up and annually until the end of study.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility criteria: DISEASE CHARACTERISTICS:

Inclusion criteria:

* Enrolled on parent protocol CRUK-BCPP-2005-01
* Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria:

  * Non-muscle-invasive tumor
  * Muscle-invasive tumor
  * Solitary G1 pTa tumor

Exclusion criteria:

* Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Fit for cystoscopy and surgical biopsy/resection

Exclusion criteria:

* HIV infection
* Any condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
state: England
Study officials:
affiliation: University of Birmingham
name: Maurice Zeegers, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02426515: Cryotherapy to Improve Outcomes in Lower Third Molar Surgery
Official title: Cryotherapy to Improve Outcomes in Lower Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Surgery
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Birmingham Community Healthcare NHS
First posted: 2015-04-27
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is looking to see whether cooling the face using a special cooling device (Hilotherm®) before and during the removal of wisdom teeth will reduce the pain and discomfort patients feel after the procedure. The surgical removal of lower third molars (wisdom teeth) is arguably the most commonly performed surgical procedure worldwide. If this study shows that application of cold before and throughout the procedure is a simple way to reduce post-operative symptoms, it could benefit thousands of patients every year.


Eligibility criteria: Inclusion Criteria:

1. Patients 18+ years requiring surgical removal of a single (unilateral) mandibular wisdom tooth
2. Tooth requiring full mucoperiosteal flap and bone removal for removal of tooth
3. Written informed consent

Exclusion Criteria:

1. Patients refusing to give written informed consent
2. Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
3. Pregnant women
4. Patients taking long-term anti-microbial or anti-inflammatory drugs
5. Patients requiring pre-operative antibiotics for surgery
6. Patients requiring concomitant extractions or contralateral lower 3rd molar removal

Primary outcomes:
measure: Post-operative pain
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Dental Hospital
Study officials:
affiliation: University of Birmingham
name: Thomas Dietrich
role: PRINCIPAL_INVESTIGATOR
References: