louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02082223: Individualized Preoperative Rehabilitation Pilot
Official title: Individualized Preoperative Rehabilitation (iPREHAB) Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Complex Gastrointestinal Surgery
Keywords: Quality of life
Deficits
Complex gastrointestinal surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A pilot to test feasibility of improving patient/caretaker quality of life and resilience.

Detailed description: Our overall goal is to investigate if pre-operative interventions can address patients' and patients' care givers quality of life/resilience deficits and thus improve outcomes. This initial pilot study will test the feasibility of offering patients and their care givers prehabilitation interventions prior to complex gastrointestinal surgery such as pancreatectomy, esophagectomy, proctectomy, or hepatectomy.

Eligibility criteria: 1. Patients who are being seen for pancreatic, esophageal, rectal or hepatic neoplastic disease, will undergo neo-adjuvant therapy and may require complex GI surgery and their care givers.
2. Are able and willing to participate in all aspects of the study; and
3. Have been provided with, understand the consent.

Primary outcomes:
measure: Feasibility
timeFrame: 3 months post surgical
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Juliane Bingener-Casey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05423223: Comparative Effects of Paraffin Bath Therapy and ESWT on Quality of Life and Sleep in De Quervain Tenosynovitis
Official title: Comparative Effects of Paraffin Bath Therapy and Extracorporeal Shock Wave Therapy on Quality of Life and Sleep in Patients With De Quervain Tenosynovitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: De Quervain Disease
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 70
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: There is no study in the literature comparing effects of both paraffin bath therapy and Extracorporeal Shock Wave Therapy (ESWT) on life and sleep quality of patients with De Quervain Tenosynovitis . The aim of this study is performing this comparison.


Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Meeting De Quervain diagnostic criteria
* Not having applied any physical therapy modality to the hand-wrist in the last 1 month
* Not using pain medication in the last 1 month,
* Not using local anesthetics or steroid injections on the hand-wrist in the last 3 months
* Have received written consent to participate in the study, and have come to the last control at the 6th week.

Exclusion Criteria:

* Neurological diseases (especially neuropathies),
* Malignancy
* Rheumatological diseases
* Pregnancy
* History of hand/wrist fracture or surgery
* Hand/wrist trauma in the last 1 month
* Coagulation disorder diseases

Primary outcomes:
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: at baseline (before the treatment)
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: 2 weeks after baseline (at the end of treatment)
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: 6 weeks after baseline (one month after the end of treatment)
measure: NEADL (Nottingham extended activities of daily living ) scale
timeFrame: at baseline (before the treatment)
measure: NEADL (Nottingham extended activities of daily living ) scale
timeFrame: 2 weeks after baseline (at the end of treatment)
measure: NEADL (Nottingham extended activities of daily living ) scale
timeFrame: 6 weeks after baseline (one month after the end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
affiliation: Yüzüncü Yıl Üniversitesi Tıp Fakültesi
name: Volkan Şah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06715423: High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards
Official title: High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Moderate Respiratory Distress
Severe Respiratory Distress
Keywords: oxygen
high flow
pneumonia
pediatrics
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: MOH Afghanistan
name: MOH Bangladesh
name: MOH Sierra Leone
name: MOH Yemen
name: MSF Médecins Sans Frontières Belgium
name: MSF Médecins Sans Frontières France
name: Fisher and Paykel Healthcare
First posted: 2024-12-04
Enrollment: 960
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSF pediatric ICU in 4 sites (Herat- Afghanistan, Kenema- Sierra Leone, Goyalmara hospital for Rohingya refugee - Bangladesh, Khamir- Yemen)

Brief summary: The purpose of this study is to prospectively evaluate the process of implementing HFNO in several MSF projects, varying according to geographical and programmatic contexts, population, health structures, human resources, and management. It will generate evidence on the operational feasibility (in terms of human resources, equipment, logistics and costs) of integrating HFNO into PICU standard of care, as well as on the users' and caregivers' perspectives on HFNO and on the children clinical outcomes observed where HFNO is implemented. This relevant information will guide MSF in the decision making of scaling up HFNO therapy in its projects.

Detailed description: Mixed method study: quantitative component for the data of the children and qualitative data for the perception for health staffs and parents

Eligibility criteria: Inclusion Criteria:

* prescription of HFNO by clinician
* parent consenting to the use of the data

Primary outcomes:
measure: Recovery with SPO2 above 92%
timeFrame: From enrollment to day 3 to 10
Secondary outcomes:
Other outcomes:
measure: Acceptability, feasibility and perception from the caretaker point of view
timeFrame: 2 weeks after hospitalisation
measure: Acceptability, feasibility and perception from the health staff point of view
timeFrame: From Month 2 until Month 12
Locations:
city: Herat
country: Afghanistan
facility: Herat regional Hospital
Study officials:
References:
Clinical trial NCT04453423: Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.
Official title: A Study of the Effect of Anlotinib, Pemetrexed or the Combination As Maintenance Therapy for Patients With Non-Squamous Non-Small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-squamous Non-small-cell Lung Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75, ECOG PS: 0\~1, estimated survival duration more than 3 months;
2. Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC;
3. Signed and dated informed consent;
4. adequate hematological, liver and renal function

Exclusion Criteria:

1. prior chemotherapy or treatment with another systemic anti-cancer agent
2. malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
3. evidence of tumor invading major blood vessels
4. current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
5. history of haemoptysis \>/=grade 2
6. clinically significant cardiovascular disease

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 NCT05029323: Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol
Official title: Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Syncope
Syncope;Heat Induced
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to compare the positivity rate associated with a novel simplified Tilt-Table (TT) test protocol versus the conventional TT protocol

Detailed description: All patients with unexplained syncope at initial evaluation with indication to perform a Head up tilt test (HUTT) will be randomized to "conventional" HUTT protocol or "fast" HUTT protocol characterized by a stabilization phase of 5 min in the supine position; a passive phase of 10 min at a tilt angle of 60 degrees; a provocation phase of further 10 min after 300 micrograms NTG sublingual spray. The novel simplified "fast" HUTT protocol has been designed to provide non inferior positivity rates as compared with the conventional protocol in the selected population.

Eligibility criteria: Inclusion Criteria:

* All patients with unexplained syncope at initial evaluation and indication to perform HUTT

Exclusion Criteria:

* No informed consent
* PM/ICD device recipients

Primary outcomes:
measure: HUTT positivity rate during passive phase
timeFrame: through study completion, an average of 1 year
measure: HUTT positivity rate during active phase
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The type of HUTT-induced syncope during passive phase
timeFrame: through study completion, an average of 1 year
measure: The type of HUTT-induced syncope during active phase
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania "Luigi Vanvitelli"
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Vincenzo Russo, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05360823: The Effect of Using a Birth Ball and Squatting Position During Labor
Official title: The Effect of Using a Birth Ball and Squatting Position During Labor on Labor Pain, Duration of Labor and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Labor Fast
Satisfaction, Patient
Keywords: Labor Pain
Birth ball
Squatting
Duration of labor
Satisfaction
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to evaluate the effect of using the birth ball and squatting position during labor on labor pain, duration of labor and satisfaction. The research is a randomized controlled experimental study. The sample of the study consisted of a total of 159 pregnant women, 53 in the birthing ball application group, 53 in the squatting group, and 53 in the control group, who met the criteria for inclusion in the study.


Eligibility criteria: Inclusion Criteria:

* No risky pregnancy
* Gestational week between 37-42
* Unopened amniotic membrane
* Those who will give birth vaginally
* In active phase
* Fluent in Turkish
* Singleton pregnancy
* Primiparous

Exclusion Criteria:

* Any complication development
* Cesarean section status

Primary outcomes:
measure: Personal and Obstetric Information Form
timeFrame: pre-intervention
measure: Visual Analog Scale (VAS)
timeFrame: latent, active and transition phase of labor
measure: Partogram
timeFrame: active phase of labor
measure: Evaluation Scale for Maternal Satisfaction with Normal Delivery
timeFrame: Postpartum at the 4th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Fatma Dünmez, Midwife
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeung MPS, Tsang KWK, Yip BHK, Tam WH, Ip WY, Hau FWL, Wong MKW, Ng JWY, Liu SH, Chan SSW, Law CK, Wong SYS. Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial. BMC Pregnancy Childbirth. 2019 May 6;19(1):153. doi: 10.1186/s12884-019-2305-8.
citation: Lavender T, Cuthbert A, Smyth RM. Effect of partograph use on outcomes for women in spontaneous labour at term and their babies. Cochrane Database Syst Rev. 2018 Aug 6;8(8):CD005461. doi: 10.1002/14651858.CD005461.pub5.
citation: Gungor I, Beji NK. Development and psychometric testing of the scales for measuring maternal satisfaction in normal and caesarean birth. Midwifery. 2012 Jun;28(3):348-57. doi: 10.1016/j.midw.2011.03.009. Epub 2011 May 4.
Clinical trial NCT01255423: Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankle Sprain
Keywords: Ankle sprain, soft tissue injury
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-07
Enrollment: 206
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: The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.


Eligibility criteria: Inclusion criteria:

1. Male or female aged 18 years and over.
2. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
3. Injury within past 12 hours.

Exclusion criteria:

1. Pain medication was taken within the 6 hours that precede randomization.
2. During the past 3 months: Grade I-III sprain of the same ankle.
3. During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
4. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
5. Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Pain on Movement
timeFrame: 72 hours
Secondary outcomes:
measure: Pain on Movement
timeFrame: 24 hours and 7 days
measure: Onset of Pain Relief
timeFrame: Day 1
measure: Tenderness
timeFrame: Change from baseline at 24 and 72 hours, 7 days
measure: Ankle Joint Function
timeFrame: 24 and 72 hours, 7 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Aventura
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Berlin
country: United States
state: New Jersey
city: Columbia
country: United States
state: South Carolina
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Novartis
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00778323: Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery
Official title: Effects of Remote Ischemic Preconditioning on Biochemical Markers and Neurological Outcomes in Patients Undergoing Elective Cervical Decompression Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervical Compression Myelopathy
Ischemia
Reperfusion Injury
Spinal Cord Injury
Keywords: remote ischemic preconditioning
cervical compression myelopathy
spinal cord
neuron-specific enolase
s-100B
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2008-10-23
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess whether a large clinical trial testing the effect of RIPC on neurologic outcome in patients undergoing elective cervical decompression surge is warranted.

Detailed description: Spinal cord ischemia-reperfusion injury commonly contribute to perioperative morbidity and mortality after elective cervical decompression surgery.Remote ischemic preconditioning(RIPC)is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide system protection from prolonged ischemia.The hypothesis of this protocol is that limb ischemic preconditioning could reduces spinal cord ischemia-reperfusion injury induced by elective cervical decompression surgery.Serum s-100B and NSE concentration will be measured before and after induction ,and at 6 hours,1,3,5 and 7days after surgery.JOA scores in all the cases will be evaluated before operation and at 7days ,1,3,6 month after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical and radiological signs of cervical compression myelopathy(ccm)
* Age 30-75
* Stage 1-2

Exclusion Criteria:

* Age\>75
* History of heart,hepatic,renal or pulmonary disease.
* History of peripheral vascular disease affecting the upper limbs.

Primary outcomes:
measure: serum concentrations of s-100B,NSE
timeFrame: 1 week or more
Secondary outcomes:
measure: a Japanese Orthopaedic Association (JOA) scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xiling Hospital,Fourth Military Medical University
name: Lize Xiong, MD
role: STUDY_CHAIR
References:
citation: Hu S, Dong HL, Li YZ, Luo ZJ, Sun L, Yang QZ, Yang LF, Xiong L. Effects of remote ischemic preconditioning on biochemical markers and neurologic outcomes in patients undergoing elective cervical decompression surgery: a prospective randomized controlled trial. J Neurosurg Anesthesiol. 2010 Jan;22(1):46-52. doi: 10.1097/ANA.0b013e3181c572bd.
Clinical trial NCT01363323: Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
Official title: A Randomized, Double-Blind, Placebo/Positive Controlled, Evaluation of the Effects of MNTX on ECG Parameters and Cardiac Repolarization in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.


Eligibility criteria: Inclusion Criteria:

1. Healthy and free of acute active illnesses
2. Males and females between the ages of 18 and 45 years, inclusive
3. Body mass index between 18-30, inclusive, and weight between 50-110 kgs
4. ECG within normal limits (including PR \<220, QRS \<110, and QTc \<450 ms.)

Exclusion Criteria:

1. Previous MNTX exposure
2. Currently pregnant or nursing
3. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or other medically significant disorders
4. Consumption of alcoholic beverages within 7 days prior to study confinement
5. Any evidence of congenital or familial long-QT syndrome
6. History of drug abuse of positive findings on urine drug screen
7. Known allergy or hypersensitivity to MNTX or its excipients, moxifloxacin, opioids, or related drugs or a history or relevant adverse drug reactions of any origin.

Primary outcomes:
measure: Effects of MNTX on QTcI duration
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References: