louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05757986: Predictive Model for PONV for Patient Received Gynecological Laparoscopic Surgery
Official title: Dynamic Predictive Model for Postoperative Nausea and Vomiting for Patient Received Gynecological Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Weifang Medical University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 659
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The female patients with gynecological diseases and requiring gynecological laparoscopic surgery.

Brief summary: This is a prospective study to dynamically predict the risk of PONV in patients undergoing gynecologic laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

-All female patients receiving gynecological laparoscopic surgery.

Exclusion Criteria:

-Patients requiring intraoperative open-surgery, requiring other procedures in addition to gynecological laparoscopy, with severe organ dysfunction, unstable postoperative vital signs or requiring transfer to ICU.

Primary outcomes:
measure: PONV
timeFrame: Within 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Weifang
country: China
facility: Weifang Medical University
state: Shangdong
Study officials:
References:
Clinical trial NCT05739786: Comparisom of Liquid Nitrogen and Vitamin D3 in The Treatment of Cutaneous Warts
Official title: Comparison of Efficacy of Liquid Nitrogen Versus Vitamin D3 in The Treatment of Cutaneous Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cutaneous Warts
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A total of 60 female patients (30 patients in each group) with cutaneious warts diagnosed by a consultant dermatologist on physical examination were included in this study.

In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of \> 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.


Eligibility criteria: Inclusion Criteria:

* Patient of cutaneous warts presented in dermatology department.

Exclusion Criteria:

* Immunosuppressed patients
* chronic skin diseases like eczema or autoimmune disease
* diabetes mellitus
* cold sensitivity , skin allergies
* pregnancy, and lactation
* periungual warts

Primary outcomes:
measure: Effectiveness of liquid nitrogen and intralesional vitamin D3 in treatment of cutaneous warts
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Sara Ilyas
state: Kpk
Study officials:
References:
Clinical trial NCT04933786: Digital Health Nudging in Adolescents With Congenital Heart Disease
Official title: Digital Health Nudging - Daily Smartphone Messages to Increase Physical Activity in Adolescents With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Physical Activity Promotion
Digital Health Nudging
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: Stiftung KinderHerz Deutschland gGmbH
First posted: 2021-06-22
Enrollment: 97
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In adolescents with congenital heart disease physical activity level is reduced which is why promotion to a more active lifestyle with an age-appropriate and modern intervention is needed. In healthy subjects digital health nudging was shown to increase physical activity. However, in adolescents with congenital heart disease such studies have not been conducted yet. In this RCT participants receive daily, short smartphone messages with the primary purpose to increase daily physical activity, which is monitored with a "Garmin vivofit jr." wearable.


Eligibility criteria: Inclusion Criteria:

* Adolescents aged 12 to 18 years inclusive
* Presence of a congenital heart defect (must be moderate or complex according to ACC criteria)
* Presence of written informed consent

Exclusion Criteria:

* Cognitive impairments that inhibit patients from understanding the tasks

Primary outcomes:
measure: Objectively measured physical activity
timeFrame: 25 weeks
Secondary outcomes:
measure: Objectively measured daily step count
timeFrame: 25 weeks
measure: Activity-related self-efficacy
timeFrame: Baseline, after 12 weeks, after 24 weeks
measure: Health-related quality of life
timeFrame: Baseline, after 12 weeks, after 24 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Congenital Heart Defects and Pediatric Cardiology, German Heart Center
state: Bavaria
Study officials:
affiliation: Technical university munich, Chair of preventive perdiatrics
name: Jan Müller, PD Dr.rer.nat
role: STUDY_DIRECTOR
References:
Clinical trial NCT00375986: A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section
Official title: A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Cesarean Section
Keywords: Cesarean delivery
Placental removal
Blood loss
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2006-09-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine if there are differences in operative blood loss with manual vs. spontaneous removal of the placenta during cesarean section.

Detailed description: Patients undergoing scheduled cesarean deliveries are randomized to manual or spontaneous placental removal.

Eligibility criteria: Inclusion Criteria:

* All term pregnant women 18 years of age and older undergoing scheduled cesarean delivery at Strong Memorial Hospital.

Exclusion Criteria:

* Prematurity (\<37 weeks)
* Preoperative chorioamnionitis
* Vaginal delivery of fetus
* Emergency Cesarean Delivery
* Patient's OB not agreeable to participating in this study.

Primary outcomes:
measure: Hematocrit levels (preoperatively and within 48 hours postoperatively)
Secondary outcomes:
measure: Number of units of blood transfused intraoperatively and postoperatively
measure: Development of uterine infection (endometritis)
measure: Length of postoperative hospital stay
measure: Operative time
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
Study officials:
affiliation: University of Rochester
name: Eva K. Pressman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00192686: Cultures a.m.Kamme-Lindbergh in Suspicion of Infected TKA
Official title: Cultures From Total Knee Arthroplasties, Obtained a.m. Kamme-Lindberg in Revision Cases.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthritis
Viral; Infection, Slow Virus
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: Cultures from total knee arthroplasties, obtained a.m. Kamme-Lindberg in revision cases.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Farsoe
country: Denmark
facility: Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division, Aalborg University Hospital, Denmark
name: Christian Pedersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04897386: Monitoring the Efficacy of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC by Sequencing of Immune Receptor Repertoire: a Prospective, One Arm Clinical Study
Official title: Monitoring the Efficacy of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC by Sequencing of Immune Receptor Repertoire: a Prospective, One Arm Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ib-IIIb NSCLC
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To observe and evaluate the efficacy and safety of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC and the relevance with Immune Receptor Repertoire


Eligibility criteria: Inclusion Criteria:

1. Age: ≥ 18 years old;
2. NSCLC confirmed by histopathology;
3. According to the doctor's advice, according to the routine diagnosis and treatment process, lung cancer patients who need radical resection and neoadjuvant therapy before operation;
4. No previous treatment for esophageal cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, hormone or immunotherapy;
5. ECoG score was 0 or 1;
6. There was no operative contraindication in preoperative organ function examination;
7. At least 6 months of expected survival
8. The laboratory examination met the following standards:

   1. Bone marrow function: hemoglobin (HB) ≥ 90g / L; White blood cell count (WBC) ≥ the lower limit of normal value; Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L； Platelet count ≥ 90 × 10\^9/L；
   2. Renal function: Cr ≤ unl (upper limit of normal value) × 5, CCR ≥ 55ml / min;
   3. Liver function: total bilirubin ≤ ULN × 1.5； ALT and AST ≤ ULN × 2.5 (patients with liver metastasis can be relaxed to ≤ 5 \* ULN);
   4. Coagulation function: international normalized ratio of prothrombin time ≤ ULN × 5, and partial thromboplastin time was within the normal range;
9. The subjects agreed and voluntarily signed the informed consent

Exclusion Criteria:

1. Allergic to the study drug;
2. History of hemorrhagic disease or with hemorrhagic disease
3. Liver and kidney dysfunction;
4. Patients with uncontrolled diseases (including but not limited to: active infection, symptomatic congestive heart failure; Myocardial infarction occurred within 3 months; Unstable angina, arrhythmia, etc.);
5. Women of childbearing age are unwilling to use contraception;
6. Lactating women;
7. For any other reason, the researchers consider it inappropriate to participate in the trial.

Primary outcomes:
measure: ORR
timeFrame: at 64th week
measure: DFS
timeFrame: at 64th week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04504786: Vitality Acupunch Exercise Program for Sarcopenia Older Adults
Official title: Effects of the Vitality Acupunch Exercise Program on the ADL and Functional Fitness of Sarcopenia Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Activities of Daily Living
Functional Fitness
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project was aimed to test the effects of a six-month VA program on the activities of daily living (ADL) and functional fitness of institutional older adults with sarcopenia.

Detailed description: A cluster-randomized controlled trial was conducted to test the effects of a six-month VA program on ADL and functional fitness (lung capacity, body flexibility, range of the joint's motion, and muscle endurance) of institutional older adults with sarcopenia. Using convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and then cluster-randomized by the facility to a VA experimental or a control group. The experimental group received the VA program led by certified instructors 3 times per week and 40 minutes per session for six months; the control group continued with their regular daily activities. One pre-test and two post-tests, three months apart, were conducted.

Eligibility criteria: Inclusion Criteria:

* age ≥ 65 years old
* have been living in the facility for at least three months
* intact cognitive function with the Short Portable Mental Status Questionnaire (SPMSQ) score ≥ 8
* hand-grip strength \< 28 kg for men and \< 18 kg for women
* calf circumference \< 34 cm for men and \< 33 cm for women

Exclusion Criteria:

* have spinal cord injury
* have severe cardiovascular or pulmonary diseases
* have musculoskeletal diseases

Primary outcomes:
measure: Lung capacity
timeFrame: 6 months
measure: Upper body flexibility
timeFrame: 6 months
measure: Lower body flexibility
timeFrame: 6 months
measure: Range of joint motion
timeFrame: 6 months
measure: Arm muscle endurance
timeFrame: 6 months
measure: Leg muscle endurance
timeFrame: 6 months
Secondary outcomes:
measure: Activities of daily living (ADL)
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Kuei-Min Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tung HT, Chen KM, Huang KC, Hsu HF, Chou CP, Kuo CF. Effects of Vitality Acupunch exercise on functional fitness and activities of daily living among probable sarcopenic older adults in residential facilities. J Nurs Scholarsh. 2022 Mar;54(2):176-183. doi: 10.1111/jnu.12723. Epub 2021 Nov 8.
Clinical trial NCT04196686: Ice Immersion Using Virtual Reality & Augmented Reality
Official title: Evaluating the Effectiveness of Immersive Technologies, Virtual Reality and Augmented Reality, to Increase Pain Threshold During Ice Immersion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Neuropathic
Pain, Acute
Keywords: Virtual Reality
Augmented Reality
Ice Immersion
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effectiveness of different technologies, Virtual Reality and Augmented Reality with modifications as passive content, active content, cognitive load modulation, and positive encouragement coaching to increase the pain threshold as assessed by immersing a hand in ice water.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* English speaking
* Hearing intact

Exclusion Criteria:

* Patients who do not consent
* Currently taking beta blockers or other chronotropic heart medication(s)
* Have a history of severe motion sickness
* Currently have nausea
* Currently experiencing seizures
* Are clinically unstable
* Have taken pain medications in the last 12 hours

Primary outcomes:
measure: VR Effect on Pain Tolerence
timeFrame: Duration of ice bath (approximately 0 - 4 minutes)
Secondary outcomes:
measure: VR's Effect on Perceived Pain Intensity
timeFrame: Duration of ice bath (approximately 0 - 4 minutes)
measure: Skin Conductance Response Density (SCRD)
timeFrame: Duration of ice bath (approximately 0 - 4 minutes)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT05449886: Prone Fluid Responsiveness in Children
Official title: Study on the Prediction of Fluid Responsiveness in Pediatric Patients Undergoing General Anesthesia With Prone Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric ALL
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In pediatric patients in the prone position, the reliability of pulse pressure variation and stroke volume variation, and pleth variability index to predict fluid responsiveness have not previously been established. Perioperatively, in this setting, optimizing fluid management can be challenging, and fluid overload is associated with both intraoperative and postoperative complications. The investigator designed this study to assess the sensitivity and specificity of baseline PPV, SVV, and PVI the tidal volume (VT) challenge (VTC) and in predicting fluid responsiveness during elective neurosurgery.


Eligibility criteria: Inclusion Criteria:

* elective neurosurgery and requiring prone positioning

Exclusion Criteria:

* (1) chronic cardiac arrhythmia; (2) depressed left (\<30% of ejection fraction) (3) patients with pulmonary disease

Primary outcomes:
measure: fluid responsiveness prediction using AUC of ROC curve analysis
timeFrame: from induction of anesthesia to end of operation, about 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
Study officials:
References:
Clinical trial NCT03065686: Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing
Official title: Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing GENEPIC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: Cleft Lip and Palate
CL/P
WES
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of NS human clefting

Detailed description: Despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of NS human clefting. Moreover, the efficiency of Whole Exome Sequencing -WES- was proven. The efficiency of WES was proven by the identification of the genes causing Freeman Sheldon and Miller's syndrome, followed by several others. In the Picardy region, management and follow-up of orofacial cleft patients are well-organised by a multidisciplinary team in the university hospital of Amiens. The investigators therefore decided to perform whole exome sequencing (WES) on precisely phenotyped non-syndromic CL/P patients followed in our center.

Eligibility criteria: Inclusion Criteria:

* Subject with a NSCL/P or CL/P of unknown etiology,
* national health care insurance holders

Exclusion Criteria:

* Subject with a CL/P of known etiology,
* Subject with a NSCL/P and an IRF6 mutation

Primary outcomes:
measure: Identification of genetic factors
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
affiliation: CHU Amiens
name: Bénédicte DEMEER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06007586: Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Study on Prevention and Treatment of CINV Induced by TC Regimen in Gynecological Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gynecological Tumor
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 138
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor.

Detailed description: The risk of vomiting caused by high-dose carboplatin is controversial, and there is currently no prevention of TC in patients with gynecological malignant tumors High-level evidence-based medical evidence for programme-induced CINV. Therefore, different guidelines recommend the best antiemetic regimen as well It's different. This study is intended to conduct a prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study The designed Phase III clinical study provides important data and basis for clinical practice and guideline formulation.

Eligibility criteria: Inclusion Criteria:

1. Age 20-75 years old;
2. ECOG PS：0～2;
3. She was diagnosed as gynecological malignant tumor and was to receive TC chemotherapy;
4. Carboplatin AUC 5～6mg/ml/min；
5. Basically normal organ function (normal bilirubin level circumference, normal range of creatinine, ALT\&lt; 2 times the upper limit of normal, AST\&lt; 2 times the upper normal value)

Exclusion Criteria:

1. Patients with previous history of chemotherapy, radiotherapy or targeted therapy;
2. Malignant tumors with brain metastases;
3. History of gastrointestinal malignancy;
4. History of brain tumor;
5. Previous gastrointestinal surgery history, such as segmental resection, (partial) gastrectomy, except intestinal polyp resection and appendectomy;
6. (incomplete) intestinal obstruction;
7. Vestibular dysfunction;
8. Massive abdominal accumulation liquid (except for those who have undergone puncture drainage);
9. Opioid concomitant drug users;
10. Diabetic.

Primary outcomes:
measure: Complete response (CR) rate in the delayed period
timeFrame: 24 hours to 7days
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Dengfeng Wang
state: Sichua
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
Study officials:
References: