louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04514081: The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.
Official title: A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Anti-PD-1 Antibody Resistant
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
6. Subjects must have received Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month.
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Primary outcomes:
measure: ORR assess by investigators per the 2014 Lugano classification
timeFrame: 3 years
measure: Number of Subjects with treatment-related adverse events (AEs)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Biotherapeutic Department of Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05034081: Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
Official title: Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric
Weight regain
Metabolism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Is post-bariatric body contouring surgery prevent weight regain or no, and what is the effect on the patient's Metabolism? Few literature studies report body contouring surgery to be positively associated with maintained weight loss after obesity surgery but the measures of outcomes are diverse, and the collective magnitude of such an association is unknown.

The changes in gastrointestinal hormones, adipokines, and cytokines as well as in hypothalamic neuropeptides and neurotransmitters resemble the changes observed in the anorexia/cachexia, suggesting that bariatric surgery triggers a catabolic state responsible for loss of appetite and prolonged body weight reduction.

Weight regain after gastric bypass surgery occurs in about half of all patients within 2 years. About 50% of patients eventually gain a little weight back after hitting their low point. We need a more thorough evaluation to determine what factors - medical, psychological, lifestyle - are involved in the weight gain. One of the factors that seem to be responsible for the degree and durability of weight loss is post-bariatric body contouring procedures. However, metabolic consequences of removing excess subcutaneous adipose tissue by body contouring procedures have to a lesser extent been explored


Eligibility criteria: Inclusion Criteria:

* Post-bariatric (sleeve) patients will do body contouring surgery.
* Post-bariatric patients has been stable within 5 kg for 3 months
* Age between 20-60 years old.
* patients use the determinant fixed diet.

Exclusion Criteria:

* Age below 20 and above 60 years old.
* Non-compliance with the fixed diet.
* psychotic patients.
* Female patients seeking pregnancy.
* Endocrine causes of obesity.
* Bariatric surgery other than sleeve.

Primary outcomes:
measure: weight changes by kilograms
timeFrame: 4 years
measure: Level of Tumor necrotizing factor alfa in blood
timeFrame: 4 years
measure: Level of BNP in blood
timeFrame: 4 years
measure: Level of high sensitive CRP in blood
timeFrame: 4 years
Secondary outcomes:
measure: Patient satisfaction score
timeFrame: 4 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Mohamed Shadad, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT04989881: Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator
Official title: Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator Training to Develop Basic Laparoscopic Skills: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of the present study is to compare the effectiveness of dry-lab laparoscopic training and robotic simulator training among medical students without any prior laparoscopic experience.

Detailed description: This study will be a randomized clinical trial conducted at the Swiss Foundation For Innovation And Training In Surgery (SFITS), which is part of the Geneva University Hospital in Switzerland. Recruitment of a sample of 100 medical students with no prior experience in laparoscopic surgery will be performed. The participants will be randomized in 2 groups (50 participants in each group). The study group will undergo a single session of training using a standard, dry-lab laparoscopic box. The control group will undergo a single session of training using the da Vinci Skills Simulator. Post-training surgical skills for both groups will be measured using exercises from the FLS manual skills assessment. The overall performance on the FLS test will be compared between the two groups .

Eligibility criteria: Inclusion Criteria:

* Medical student at the University of Geneva

Exclusion Criteria:

* Previous laparoscopic experience
* Stereoblindness

Primary outcomes:
measure: FLS score post-training session
timeFrame: Up to 1 hour after the beginning of the exam session.
Secondary outcomes:
measure: Times needed to perform training exercises
timeFrame: Up to 1 hour after the beginning of the training session
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Pouya Iranmanesh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06491381: Post Cesarian Section Wound Infections At Emergency Room
Official title: Incidence of Post Cesarean Section Wound Infections At Emergency Unit At E-Hhussien University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound Infection
Keywords: Surgical site infections
Elective Cesarean delivery
Emergency Room
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include 220 patients undergoing cesarean section at El-hussien Hospital, equally divided into two groups of 110 each. One group will consist of emergency cesarean deliveries performed in the Emergency Unit, excluding cases with premature rupture of membranes. The other group will include elective, scheduled cesarean deliveries. This diverse population will allow for a comprehensive comparison of surgical site infection rates and other outcomes between emergency and elective cesarean sections.

Brief summary: The goal of this observational study is to compare the incidence of post-cesarean section wound infections between emergency and elective cesarean deliveries at El-hussien Hospital. The main questions it aims to answer are:

Is there a difference in surgical site infection rates between emergency and elective cesarean sections? What are the other outcome measures associated with emergency versus elective cesarean deliveries?

Participants will be 220 patients undergoing cesarean section, divided into two groups:

110 patients undergoing emergency cesarean delivery in the Emergency Unit 110 patients undergoing elective cesarean delivery

Researchers will compare the emergency cesarean group to the elective cesarean group to see if there are differences in surgical site infection rates and other relevant outcome measures.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Managed with elective CS or Emergency CS
* BMI \< 25 Kg/m2

Exclusion Criteria:

* Immunodeficiency or diabetes.
* Premature rupture of membrane
* Bleeding disorder.
* Previous uterine surgery except previous CS.
* Malignancy.
* Refusal to participate.

Primary outcomes:
measure: Post Caesarian Section Wound Infections
timeFrame: 6 weeks after surgery.
Secondary outcomes:
measure: Wound Healing Complications
timeFrame: 6 weeks after surgery.
measure: Length of Hospital Stay
timeFrame: 6 weeks after surgery.
measure: Surgical Site Pain
timeFrame: 6 weeks after surgery.
measure: Antibiotic Usage
timeFrame: 6 weeks after surgery.
measure: Patient Satisfaction
timeFrame: 6 weeks after surgery.
measure: Keloid formation
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Hussein University Hospital
Study officials:
References:
Clinical trial NCT05884281: Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
Official title: Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Peripheral Neuropathy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, roflumilast potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.


Eligibility criteria: Inclusion Criteria:

1. Breast cancer patients who will receive paclitaxel post-anthracycline therapy.
2. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
3. Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine \< 1.5 mg/dl).

Exclusion Criteria:

1. Patients with signs and symptoms of clinical neuropathy at baseline.
2. Patients with diabetes mellitus or alcoholic disease.
3. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.

Primary outcomes:
measure: Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
timeFrame: 8 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04693481: Effects of Nature Exposure Intervention on Soccer Performance Among Mentally Fatigued University Players
Official title: Effects of Nature Exposure Intervention on Self-Regulation and Decision-making in Mentally Fatigued University Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Fatigue
Keywords: decision-making skills
self-regulation
mental fatigue
soccer performance
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomly assign subjects into the experimental groups and the control group
Primary purpose: TREATMENT

Brief summary: The current study is going to investigate the nature exposure intervention on the ability of self-regulation and decision-making skills among mentally fatigued soccer players. The subjects will be instructed to view some nature photos, which can facilitate the recovering process for directed attention and the ability of self-regulation. Thus, to see the improvement in decision-making skills.

Detailed description: The intervention of this study is nature exposure, specifically, instruct subjects to view and immerse in some nature photos due to the humanity of biophilia.

The condition of mental fatigue will be induced by the Stroop task.

Before the intervention or process of viewing photos, the baseline will be recorded to compare the post-test value of self-regulation and the score of decision-making skills.

Moreover, the different durations of viewing photos will be implemented to identify the optimal selection.

Eligibility criteria: Inclusion Criteria:

* The selection of the participants will be every position without the goalkeeper. The age of them will be at 18-24 years. Only male players will be selected. Players should have at least played from the senior school and have 3 years' training experience.

Exclusion Criteria:

* The study will exclude color blindness, for the Stroop task will involve color. Self-reports should be free of any known disease or sleep disorder and not currently taking any medication.

Primary outcomes:
measure: Heart Rate Variability (HRV) will be the indicator of physiological self-regulation and measured by Polar H10 HRV belt
timeFrame: 2 weeks
measure: State anxiety will be the indicator of psychological self-regulation and measured by Competitive State Anxiety Inventory-2
timeFrame: 2 weeks
measure: The soccer decision-making skills will be measured by TacticUP soccer performance online system
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Sun He
state: Henan
Study officials:
References:
Clinical trial NCT04941781: PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers
Official title: A Phase 1, Open-label Study of PIPE-307 to Determine Muscarinic Type I Receptor (M1AChR) Occupancy Parameters by [11C] PIPE-307 PET Imaging in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Lead sponsor: Contineum Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 6
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, single-center, open-label, adaptive-design PET study to investigate the occupancy of brain muscarinic Type 1 receptors (M1AChR) by PIPE-307 in healthy volunteers.

Detailed description: This is a Phase 1, single-center, open-label, adaptive-design study to investigate the occupancy of brain M1AChR after a single oral dose of PIPE-307 in healthy volunteers by positron emission tomography (PET) using the radioligand \[11C\] PIPE-307.

This study will have an adaptive design to adequately evaluate the relationship between PIPE-307 exposure and brain M1AChR occupancy.

Eligibility criteria: Key Criteria:

* Normotensive male or female volunteers between 25-65 years old
* Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine

Key Exclusion Criteria:

* Clinically relevant abnormal findings at the screening assessments
* Clinically relevant abnormal medical history or concurrent medical condition
* Acute or chronic illness
* Contraindications to MRI, CT, PET, or arterial cannulation procedures
* Significant exposure to research related radiation or other exposure (defined as ICRP category IIb or no more than 10 mSv)
* Positive tests for hepatitis B surface antigen (HBsAg) \& Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody
* Drug or alcohol abuse
* Smoke more than 10 cigarettes daily
* Loss of more than 400 mL blood
* Vital signs or ECGs outside the acceptable range

Primary outcomes:
measure: M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
References:
Clinical trial NCT01885481: Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone
Official title: Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone in Patients With Spinal Pain: a Prospective, Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Neck Pain
Keywords: dexamethasone
betamethasone
epidural steroid injection
comparative effectiveness research
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Particle steroid drug such as triamcinolone has been used widely for epidural steroid injection (ESI) treatment in Korea. However, Korea FDA recently prohibit ESI using triamcinolone, following the regulation of US FDA. Therefore, dexamethasone and betamethasone become only candidate drugs for ESI in Korea and the investigators are curious about the effectiveness and safety of both drugs due to limitation of information about comparison of two drugs in previous literature. So, this study aims to compare the effectiveness and safety of both drugs and our hypothesis is that there is no difference of the effectiveness between dexamethasone and betamethasone at 2 weeks after ESI.


Eligibility criteria: Inclusion Criteria:

1. patients with spinal pain (i.e.neck pain, back pain, or radiculopathy..)
2. patients with informed consent
3. visual analog scale (VAS) is five or more in 10-point scale at screening
4. sustained spinal pain, regardless of sufficient conservative treatment (i.e. oral medicine, physical therapy..)

Exclusion Criteria:

1. age of patient less than 19 years
2. relative contraindication of epidural steroid injection, as follows:

   * pregnant or breast-feeding state
   * uncontrolled coagulopathy
   * suspected of active infection state
   * uncontrolled diabetes mellitus
   * previous history of adverse event related to epidural steroid injection

Primary outcomes:
measure: the proportion of patients with pain improvement
timeFrame: baseline and 2 weeks
Secondary outcomes:
measure: incidence of adverse events
timeFrame: during 12 weeks after epidural steroid injection
measure: pain relief
timeFrame: baseline and 2 weeks
measure: disability improvement
timeFrame: baseline and 2 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Joon Woo Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061281: Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Official title: Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aphakia
Keywords: Aphakia following refractive lensectomy to treat presbyopia
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 40
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 compare the visual outcomes with bilateral implantation of Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18 or greater
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
* Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
* Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
* Naturally dilated pupil size (in dim light) \> 4.0 mm (with no dilation medications) for both eyes
* Preoperative corneal astigmatism of 1.0 D or less
* Clear intraocular media other than cataract
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Use of systemic or ocular medications that may affect vision
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
* Subjects with diabetes mellitus
* Uncontrolled systemic or ocular disease
* History of ocular trauma or prior ocular surgery
* Amblyopia or strabismus
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
* Subjects who may be expected to require retinal laser treatment or other surgical intervention
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
* Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
* Requiring an intraocular lens \< 15.0 or \> 26.0 diopters

Primary outcomes:
measure: Refraction
timeFrame: 1 year
measure: Distance Visual Acuities
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Coral
country: United States
facility: Farrell Tyson
state: Florida
Study officials:
References: