louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00643721: Body Water Content Sensor
Official title: Body Water Content Sensor
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Keywords: Young healthy athletes
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young healthy athletes

Brief summary: Evaluation of hydration status during exercise and heat exposure.

Detailed description: Evaluation of hydration status during exercise and heat exposure.

Eligibility criteria: Inclusion Criteria:

* Age 18-35
* Participates in regular exercise
* Able to tolerate exercise in the heat

Exclusion Criteria:

* Abnormal hemoglobin
* Any exercise limitations
* Pregnancy
* Cardiovascular or orthopedic disease/conditions

Primary outcomes:
measure: Body weight and hydration status
timeFrame: Before exercise and following dehydration
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Institute for Human Performance
state: New York
Study officials:
References:
Clinical trial NCT06760364: A Clinical Study of CHT102 in MSLN-Positive Advanced Pancreatic Cancer
Official title: A Single-Arm, Open-Label, Phase I Study of CHT102 for MSLN-Positive Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Pancreatic Cancers
Keywords: Allogeneic CAR-T
Safety
Efficacy
PK
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
First posted: 2025-01-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer

Detailed description: 3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and sign a written informed consent documen；
2. At the date of signing ICF, 18 \~70 years old, male or female；
3. Histopathological confirmed advanced or metastatic pancreatic cancer patients who have failed to standard treatment or intolerance with standard treatment；
4. Positive mesothelin expression;
5. At least one measurable lesion at baseline per RECIST version 1.1；
6. The expected survival time is more than 12 weeks;
7. ECOG 0-1 points;
8. Adequate organ functions.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: At 4 weeks, and overall
measure: Disease control rate (DCR)
timeFrame: At 4 weeks, and overall
measure: Progress-free survival(PFS)
timeFrame: 2 years
measure: Overall survival (OS )
timeFrame: 3 years
measure: pharmacokinetics (PK)
timeFrame: 6 months
measure: PD
timeFrame: 6 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
Study officials:
References:
Clinical trial NCT03874364: The Effect of Intraurethral Lidocaine Gel on Pain Perception During Flexible Cystoscopy
Official title: The Effect of Intraurethral Lidocaine Gel in Comparison With Plain Lubricating Gel on Pain Perception During Flexible Cystoscopy: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flexible Cystoscopy
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 280
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Flexible cystoscopy is routinely performed by urologists. Many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. Thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of cystoscopy.

In this study the impact of lidocaine gel, patient counseling and monitoring regarding pain perception during flexible cystoscopy are investigated.


Eligibility criteria: Inclusion Criteria:

* Men 18 - 80 years
* Given indication for flexible cystoscopy
* Written informed consent

Exclusion Criteria:

* Allergy to amid anesthetics
* Urinary tract infection
* Use of analgesics in the previous 24 hours and chronic intake of analgesics
* Dementia
* Presence of a sensory disorder such as or spinal cord injury
* Indwelling catheter carrier

Primary outcomes:
measure: Pain based on a numeric rating scale
timeFrame: During flexible cystoscopy
Secondary outcomes:
measure: Pain based on a numeric rating scale
timeFrame: Immediately before flexible cystoscopy
measure: Pain based on a numeric rating scale
timeFrame: 10 min after flexible cystoscopy
measure: Pain based on a numeric rating scale
timeFrame: 3 days after flexible cystoscopy
measure: Pain based on a verbal rating scale
timeFrame: Immediately after flexible cystoscopy
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Klinik für Urologie, Kantonsspital Luzern
Study officials:
References:
Clinical trial NCT04134364: The Effect of Lamina-G on Gastrointestinal Symptom After Gastric Biopsy
Official title: The Effect of 3-day Oral Administration of Lamina-G on Epigastric Pain or Soreness After Gastric Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Symptom
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open labeled, single-center randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Sometimes, subjects complain about gastrointestinal symptoms after esophagogastroduodenoscopy and biopsy. The aim of this study is to investigate the effect of sodium alginate (Lamina-G®) on biopsy-related gastrointestinal symptom.

Detailed description: This study is an open labeled, single-center randomized controlled trials. Patients who underwent upper enoscopy with biopsy were randomly assigned to medication and control group. In the medication group, sodium alginate was administered after EGD during 3 days. All patients underwent a questionnaire to check the presence of gastrointestinal symptoms at baseline and on the day after return home. After 3 days, gastrointestinal symptoms were investigated by telephone survey. Gastrointestinal symptom was scaled by upper gastrointestinal symptom rate score (GSRS). Upper GSRS contains 8 items and 3 scales; abdominal pain (abdominal pain, epigastric pain/hunger soreness, nausea), reflux symptom (Heartburn/reflux/belching gas), indigestion symptom (abdominal distension, borborygmus).

Eligibility criteria: Inclusion Criteria:

Age from 18 to 80 years Persons who assigned on the written consent for the clinical trial. Persons who underwent upper endoscopy and gastric biopsy

Exclusion Criteria:

Gastrectomy Severe cardiovascular, pulmonary, or endocrine disease Renal or hepatic dysfunction Hematologic disease Gastric cancer Active peptic ulcer User of proton pump inhibitor, H2 blocker, mucoprotectant Immediate significant bleeding after biopsy Pregnant women Allergy history for sodium alginate

Primary outcomes:
measure: gastrointestinal symptom
timeFrame: baseline endoscopy (T0)
measure: gastrointestinal symptom
timeFrame: within 24 hours after endoscopy (T1)
measure: gastrointestinal symptom
timeFrame: 3 days after endoscopy (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References:
Clinical trial NCT05277064: Optimal Insertion Depth of FOB for Oral FOB Intubation
Official title: Optimal Preliminary Insertion Depth of Fiberoptic Bronchoscope for Visualization of Glottic Opening in Oral Fiberoptic Intubation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: General Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2022-03-14
Enrollment: 211
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients requiring tracheal intubation for general anesthesia without exclusion criteria of our study

Brief summary: For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.

The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.

Detailed description: For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.

The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.

The investigators will enroll the subjects of the present study after obtaining the written consent.

After enrollment, the investigators will measure some anatomical distance, such as patient height.

After induction of anesthesia and muscle relaxation for tracheal intubation, An investigator who has experiences of numerous fiberoptic intubation will measure the optimal preliminary insertion depth of the fiberoptic bronchoscope from the philtrum, the upper lip, or the incisors for oral fiberoptic intubation, with the aid of assistants. Then, tracheal intubation with a laryngoscope as a routine manner of our institute.

The investigators will calculate the mean value of the optimal depth and find out an formula for that from our data.

Eligibility criteria: Inclusion Criteria:

* patients requiring tracheal intubation for general anesthesia

Exclusion Criteria:

* do not agree to participate in the study
* emergency surgery
* predicted difficult intubation
* very weak teeth (especially central teeth)

Primary outcomes:
measure: The length of optimal preliminary insertion depth of FOB (centimeters)
timeFrame: during tracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jung-Man Lee, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02345564: Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery
Official title: Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteochondral Lesion of Talus
Degenerative Lesion of Articular Cartilage of Knee
Lead sponsor: Barmherzige Brüder Eisenstadt
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Osteochondral lesions in knee and ankle are injuries commonly seen in young patients. MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects.

This prospective study follows patients treated with MaioRegen implants from pre-surgery until 24 months post-surgery.


Eligibility criteria: Inclusion Criteria:

* single osteochondral lesion in knee/ankle (2-4 sq cm)

Exclusion Criteria:

* multiple osteochondral lesions
* pre-existing injuries/arthropathies

Primary outcomes:
measure: MRI imaging - gap between cartilage-implant surface in mm
timeFrame: 18 months post surgery
Secondary outcomes:
measure: clinical outcome measurement
timeFrame: pre-surgery
measure: clinical outcome measurement
timeFrame: 6 months post-surgery
measure: clinical outcome measurement
timeFrame: 12 months post-surgery
measure: clinical outcome measurement
timeFrame: 18 months post-surgery
measure: clinical outcome measurement
timeFrame: 24 months post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: Barmherzige Brueder Eisenstadt
name: Richard Kellner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barmherzige Brueder Eisenstadt
name: Harald Boszotta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01438164: Cost-effectiveness of FDG-PET
Official title: Estudo de Custo-efetividade Para o Sistema único de Saúde - SUS Sobre o Exame de Metabolismo de Glicose Marcada Com Flúor-18 Pela Tomografia de emissão de pósitron-PET
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncologic Patients
Keywords: FDG-PET
cancer
staging
Evaluate the cost impact in the evaluation of oncologic patients.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2011-09-21
Enrollment: 500
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 oncologic patients

Brief summary: Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil.

Detailed description: To provide detailed information about cost and effectiveness of FDG-PET in multiple oncological diseases, such as Lymphoma, lung cancer and esophageal cancer.

Eligibility criteria: Inclusion Criteria:

* Cancer

Exclusion Criteria:

* Other malignancy
* Uncontrolled Diabetes
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04680364: Effects of Dance on Reaction Time in Experienced Older Adults
Official title: Effects of Ballroom Dance on Physical Fitness and Reaction Time in Experienced Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: physical activity
partnered dances
cognitive functions
fall prevention
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of this study was to investigate the effects of 6-month ballroom dance (3 times/wk) on physical fitness and reaction time in twenty- four experienced older adults. Body composition, handgrip test, standing long jump test, step test, one-legged stance balance test, and reaction time (RT) test were assessed before and after 6 months (T6) of dance practice. RT was re-evaluated after 4 months (T10).


Eligibility criteria: Inclusion Criteria:

* dance practice (dance average years = 11 years)

Exclusion Criteria:

* functional inabilities
* cardiovascular diseases
* prosthesis

Primary outcomes:
measure: Change From Baseline in Reaction time at 6 Months
timeFrame: baseline, 6 months and 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Dance School "Free Dance"
state: Calabria
Study officials:
References:
citation: Vaccaro MG, Izzo G, Ilacqua A, Migliaccio S, Baldari C, Guidetti L, Lenzi A, Quattrone A, Aversa A, Emerenziani GP. Characterization of the Effects of a Six-Month Dancing as Approach for Successful Aging. Int J Endocrinol. 2019 Jun 17;2019:2048391. doi: 10.1155/2019/2048391. eCollection 2019.
citation: Kattenstroth JC, Kalisch T, Holt S, Tegenthoff M, Dinse HR. Six months of dance intervention enhances postural, sensorimotor, and cognitive performance in elderly without affecting cardio-respiratory functions. Front Aging Neurosci. 2013 Feb 26;5:5. doi: 10.3389/fnagi.2013.00005. eCollection 2013.
citation: Kattenstroth JC, Kalisch T, Kolankowska I, Dinse HR. Balance, sensorimotor, and cognitive performance in long-year expert senior ballroom dancers. J Aging Res. 2011;2011:176709. doi: 10.4061/2011/176709. Epub 2011 Sep 25.
Clinical trial NCT04016064: Temperature and Healing in Treatment of Gingival Enlargement
Official title: Evaluation of Temperature and Healing in Treatment of Gingival Enlargement Using Different Gingivectomy Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Enlargement
Keywords: gingival enlargement, Er:YAG, Nd:YAG, electrosurgery
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study was designed as a controlled clinical study with a randomized design. The study protocol was approved by the local ethical committee of Clinical Studies of Ondokuz Mayis University. The study population consisted of 37 participants (19 women, age 23.10±2.78, 18 men age 21.11±2.63).
Primary purpose: DIAGNOSTIC

Brief summary: Aim: Gingival enlargement is a common clinical condition which requires surgical approaches to alleviating these enlargement areas. The aim of this study was to investigate epithelization, gingival temperature, inflammation and pain levels in post-operative healing process in 4 different gingivectomy techniques including Er:YAG laser, Nd:YAG laser, electrosurgery and conventional gingivectomy in treatment of chronic inflammatory gingival enlargements.

Material and Method: A split-mouth designed study was conducted on 37 systemically healthy patients consisting of 19 females and 18 males, who had gingival enlargement areas on the left and right of maxillary and mandibular anterior regions. Gingival crevicular fluid (GCF) samples were collected, clinical periodontal parameters and gingival temperature levels were recorded at baseline and in the postoperative period. The gingival temperature was measured during surgical procedures. Gingival temperature and epithelization levels in 3rd, 7th, 10th and 15th days; GCF levels in 15th, 30th, and 90th days and pain levels in 2nd and 8th hours and between 1st-7th days of post-operative healing process were evaluated.


Eligibility criteria: Inclusion Criteria:

* systemically healthy individuals
* the existence of at least 20 functioning teeth, the existence of chronic inflammatory gingival enlargement in anterior quadrants.

Exclusion Criteria:

* pregnancy/lactation
* drug use, previous periodontal therapy within 6 months
* previous antibiotic use within 6 months, smoking
* the existence of attachment/bone loss. .

Primary outcomes:
measure: Epithelization
timeFrame: Epithelization was evaluated at postoperative 7th day
Secondary outcomes:
measure: Gingival temperature
timeFrame: The gingival temperature was measured during surgical procedures
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
References:
Clinical trial NCT05686564: Early Access Program for ALXN1840 in Patients With Wilson Disease
Official title: Early Access Program for ALXN1840 in Patients With Wilson Disease
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Wilson Disease
Keywords: Wilson Disease
ALXN1840
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-17
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.

Detailed description: To provide access to ALXN1840 treatment, an investigational medicinal product (IMP) that has not yet been granted marketing authorization, to participants who complete Studies ALXN1840-WD-205, WTX101-301, or ALXN1840-WD-302, or other studies with ALXN1840 who, in the opinion of the Treating Physician, may benefit from continued treatment with ALXN1840, and who meet the eligibility criteria described in this protocol.

Eligibility criteria: Inclusion Criteria:

1. ≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840.
2. Confirmed diagnosis of WD.
3. Has completed one of the following ALXN1840 clinical studies:

   1. ALXN1840-WD-205
   2. WTX101-301
   3. ALXN1840-WD-302
   4. Other ALXN1840 studies
4. In the Treating Physician's medical opinion, the potential benefits of treatment with ALXN1840 outweigh the potential risks for the participant.
5. Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP.
6. Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance.

Exclusion Criteria:

1. Eligible for and able to participate in an Alexion-sponsored study of ALXN1840.
2. Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason.
3. Has decompensated hepatic cirrhosis.
4. Model for End-Stage Liver Disease (MELD) score \> 13.
5. Modified Nazer Score \> 7.
6. End-stage renal disease on dialysis (chronic kidney disease stage 5 \[CKD 5\]) or creatinine clearance \< 30 mL/min.
7. Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840.
8. Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: