louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03405324: Effect of tDCS of the Motor Cortex on Chemotherapy Induced Nausia and Vomiting
Official title: Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: brain stimulation, tDCS, nausea and vomiting
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: this work is looking for the effect of tDCS of the motor cortex on the chemotherapy induced nausea and vomiting in cancer breast patients

Detailed description: Chemotherapy has played an important role in improving patient outcomes in oncology and is a cornerstone of therapy for most patients with cancer. Of the adverse effects, none is more feared than chemotherapy-induced nausea and vomiting (CINV).

Nausea and vomiting can adversely affect patients' quality of life and make it difficult for them to perform their activities of daily living. Uncontrolled CINV can give rise to medical complications, including poor nutrition, dehydration, electrolyte imbalances, and physical and mental deterioration.The introduction and development of antiemetic drugs have significantly improved the ability of clinicians to control CINV. The mainstays of antiemetic therapy include serotonin (5-HT3) receptor antagonists (RAs) and neurokinin 1 (NK-1) RAs. Researchers and patients are seeking additional methods of controlling CINV, such as non-drug therapies. Transcranial direct current stimulation (tDCS) is a relatively simple technique requiring only a few parts.

Eligibility criteria: Inclusion Criteria:

* breast cancer therapy receiving anthracyclin based adjuvant chemotherapy and prophylaxis against nausea and vomiting

Exclusion Criteria:

* patients with intracranial metallic devices or with pacemakers or any other device.
* patients with extensive myocardial ischemia
* patients known to have epilepsy patients refusal.

Primary outcomes:
measure: Cumulative of nausea scoring
timeFrame: the first 72 hours after the infusion of chemotherapy
Secondary outcomes:
measure: cumalative vomiting scoring
timeFrame: the first 72 hours after the infusion of chemotherapy
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
References:
citation: Kamal SM, Elhusseini NM, Sedik MF, Mohamad MF, Khedr EMH, Kotb HIM. Effect of Transcranial Direct Current Brain Stimulation of the Motor Cortex on Chemotherapy-Induced Nausea and Vomiting in Female Patients with Breast Cancer. Pain Med. 2022 Mar 2;23(3):571-578. doi: 10.1093/pm/pnab313.
Clinical trial NCT06924424: Aponermin, Pomalidomide, Dexamethasone for Patients With Relapsed/ Refractory Multiple Myeloma
Official title: Aponermin, Pomalidomide, Dexamethasone for Patients With Relapsed/ Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Myeloma, Neoplasms
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 105
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: This study aims to evaluate the efficacy and safety of a three drug combination therapy of aponermin, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple myeloma


Eligibility criteria: Inclusion Criteria:

1. RRMM patients who have received 1-3 line treatment;
2. Age above 18 years old, male or female not limited;
3. ECOG score ≤ 2;
4. Expected survival period is greater than 3 months;
5. For female patients, (1) they have been menopausal for at least 24 months before the screening visit, or have undergone surgical contraception; (2) Women with fertility must have two negative urine HCG pregnancy tests within 72 hours before starting to take the study drug; For male patients must agree to absolute abstinence or effective barrier contraception throughout the entire study treatment period until 28 days after the last study drug treatment, and have no sperm donation behavior;
6. The patient understands the purpose and steps of this trial, voluntarily participates in this trial, and signs a written informed consent form.

Exclusion Criteria:

1. Allergic or intolerant to the investigational drug or its components;
2. Received any experimental drug treatment within 4 weeks;
3. Simultaneously suffering from other tumors, or having undergone anti-tumor treatment (including major surgery) in the past 4 weeks;
4. Currently, there are poorly controlled heart diseases, such as heart function grade III or IV (NYAH classification),uncontrolled atrial fibrillation, unstable angina, and myocardial infarction within the 12 months prior to enrollment;
5. Suffering from mental illness;
6. Accompanied by severe lung infection, skin and soft tissue infection, or urinary tract infection;
7. There was a serious thrombotic event before treatment;
8. Unable or unwilling to receive prophylactic antithrombotic therapy;
9. Serious, uncontrolled medical disorders or active infections;
10. Researchers determine situations that are not suitable for inclusion.

Primary outcomes:
measure: Overall Response
timeFrame: 4 months
Secondary outcomes:
measure: PFS
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT05088824: When and Why Desarda Repair
Official title: When and Why Desarda Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A prospective clinical trial will be conducted on 30 patients diagnosed with oblique inguinal hernia . The study population will go for hernia repair by Desarda technique .

The treatment will be herniorrhaphy. All the patients will be followed up after the 1st week, 1st month, 3 month and after 6 month . The efficacy and adverse effects will be compared by statistical analysis.

Brief summary: One of the most significant subjects studied in abdominal wall surgery is inguinal hernia. Its management is very codified.

The main factors evaluating efficient hernia surgery are not only the rate of complications (recurrence and groin pain essentially) but also cost and time to return to normal activities.

Desarda technique is a non-mesh technique described first in 2001. This surgical technique uses a flap of external oblique aponeurosis in place of a mesh. Its singularity remains its low cost, no use of mesh, and less extensive dissection

Mesh repair has its own limitations; it is unphysiological as mesh is used. Chronic inguinal pain, seroma formation, foreign body sensation, risk of mesh infection are common complications and not recommended in strangulated hernias and extra cost involved by the mesh itself.

It involves use of undetached strip of external oblique aponeurosis to strengthen the posterior wall of the inguinal canal which is based on the physiological principles. This is a physiological repair and is tension free, can be used in strangulated hernia. Recurrence and complication rates equal to or less than Lichtenstein's repair. It's a simple procedure, early ambulation and less time of hospital stay, low cost for the patient as mesh is not used and most importantly no question of mesh related complications such as mesh rejection, infection, migration and foreign body sensation and chronic groin pain which is comparatively low in this procedure.


Eligibility criteria: Inclusion Criteria:

* primary inguinal hernia
* Aged 18 and above
* reducible inguinal or inguino-scrotal hernia

Exclusion Criteria:

* Obstructive uropathy or chronic obstructive pulmonary disease
* incarcerated hernia
* recurrent hernia
* bilateral hernia
* active infection at groin area
* pantalloon hernia

Primary outcomes:
measure: postoperative hospital stay
timeFrame: 6 month
measure: chronic pain
timeFrame: 6 months
measure: recurrence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04042324: A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
Official title: A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: Rockwell Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via separate routes.


Eligibility criteria: Inclusion Criteria:

1. Adult hemodialysis patients ≥18 years of age.
2. Signed informed consent to participate in the study.
3. Stable on hemodialysis prescription for ≥3 months.
4. Hemoglobin concentration \>9.5 g/dL.
5. Serum TSAT ≥20%.
6. Able to receive continuous heparin infusion as their anticoagulation protocol.
7. Receiving hemodialysis via AV (arteriovenous) fistula or graft.
8. Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

Exclusion Criteria:

1. Active bleeding disorder (GI, skin, nasal...)
2. Receiving hemodialysis via catheter.
3. Receiving heparin free dialysis.
4. Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
5. Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.
6. Receiving oral anti-coagulants or anti-platelet agents.
7. Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.

Primary outcomes:
measure: Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
timeFrame: 8 hours
Secondary outcomes:
measure: Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
timeFrame: 4 hours
measure: aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
timeFrame: 4 hours
measure: TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
timeFrame: 4 hours
measure: Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
timeFrame: 8 hours
measure: Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
timeFrame: 8 hours
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Rockwell Medical
name: Raymond Pratt, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04148924: Comparison Between the Assessment of Anxious and Depressive Symptomology
Official title: Comparison Between the Assessment of Anxious and Depressive Symptomology by the Patient and the Evaluation of the Patient's Symptoms by Caregivers: a Pilot Study Carried Out in a French Palliative Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients hospitalized in our palliative care unit

Brief summary: In palliative care, anxiety and depression in advanced cancer are under evaluated, under diagnosed and therefore under treated. 5 to 30% of patients present anxious and depressive disorders.

Physical symptoms are easy to assess. But in palliative care it is important to take care of moral suffering.

However, evaluation and management of patient's anxiety and depressive symptoms are difficult for physicians and caregivers.

The investigators would like to specifically compare the patient's evaluation of anxious and depressive symptomatology in palliative care with the evaluation by the physician, the nurse and the caregiver.

Then the investigators will try to collect the caregivers's difficulties in the management of anxious and depressive symptoms.


Eligibility criteria: Inclusion Criteria:

Patients :

* Adult patients (18 years and over)
* Advanced cancer stage
* Patients hospitalized less than 72 hours in Lyon Sud palliative care unit
* Sufficient general conditions to complete survey
* Absence of cognitive disorders
* Agreement to participate at the study

Medical Staff:

- Working full time or part time in the USP or the PMSC of CHLS

Exclusion Criteria:

Patients :

* Minor patients
* Patients hospitalized more than 72 hours in Lyon Sud palliative care unit
* Presence of cognitive disorders
* Alteration of general conditions
* Refusal to participate at the study

Primary outcomes:
measure: Comparison of the anxious and depressive symptomatology of hospitalized patients in palliative care unit (USP) evaluated on the one hand by the patient himself and on the other hand, in hetero evaluation, by caregivers.
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Audrey FAWOUBO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542424: An Observational Study in Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes Mellitus
Official title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 1889
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Macedonian people with diabetes mellitus (Type 1 or Type 2)

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Macedonian people with diabetes mellitus (Type 1 or Type 2)

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Percentage of subjects reaching HbA1c target of maximum 7.0%
measure: Postprandial plasma glucose (PPG)
measure: Fasting plasma glucose (FPG)
measure: Change in body weight
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Dimitrovski, Cedomir and Smokovski, Ivica and Makrevska, Snezana and Mileva, Iskira and Kostojcinoska, Mira (2009) Significant Improvements in Glycaemic Control without Weight Gain with Insulin Detemir in Clinical Reality: Experience from Macedonian Clinical Practice. In: ADA Congress 2009, 05-09 June 2009, New Orleans, USA.
Clinical trial NCT04467424: Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
Official title: TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Procedure, Unspecified
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Two hundred children aged 1-12 years undergoing short surgery will be randomized into two groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used. Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU) will be recorded.

Detailed description: Aim of the research: In this study investigators want to examine the effectiveness of the use of ketofol and a mixture of ketofol and lidocaine on the total consumption of opioids and on the postoperative recovery of pediatric patients. Investigators will evaluate the safety, efficacy, and outcomes of the anesthesia procedure with respect to the administration of different anesthetics, specific pharmakocinetic profiles and compare the length of recovery between patients in two groups.

Including criteria: children aged 1 to 12 years who underwent short surgery (up to 60 min).

Primary and secondary outcome measures: The primary outcome of this study will be extubation time and the secondary outcome will be time spend in PACU.

Description of the study: Each subject included in the study will be given general anesthesia with ketofol or ketofol and lidocaine, with the addition of fentanyl. After 20 s the LMA will be placed. Maintenance of anesthesia will be performed using an air / oxygen mixture (50% / 50%) and an infusion of ketofol or ketofol and lidocaine. Ketofol will be prepare in a ratio of 1: 4 for induction and 1: 7 for maintenance. The same mixtures of ketofol will be added 1 ml of 2% lidocaine for the second group of patients. After extubation, patients will be transferred to the PACU.

Eligibility criteria: Inclusion Criteria:

* surgical procedures max 60 min ASA I and II

Exclusion Criteria:

* ASA \> II surgical procedures longer than 60 min

Primary outcomes:
measure: Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children
timeFrame: up to 600 seconds
measure: Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU
timeFrame: up to 40 minutes
Secondary outcomes:
measure: Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption
timeFrame: up to 60 minutes
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital of Split
Study officials:
References:
Clinical trial NCT00700024: Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men
Official title: The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypogonadism
Metabolic Syndrome
Keywords: Body composition
Physical activity
Metabolic syndrome
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 60
Sex: MALE
Minimum age (years): 65
Maximum age (years): 78
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of training and testim on Hypogonadism.

Detailed description: The effect of testim and training in hypogonadal men.

Eligibility criteria: Inclusion Criteria:

* Male 65-78
* Bioavailable testosterone \< 7.3 nmol/L
* Waist \> 94 cm

Exclusion Criteria:

* Haematocrit \> 0.50
* Known c. prostate or PSA \> 3 Myg/L
* Known malignant disease
* Alcohol or drug abuse
* BMI \> 40 kg/m2
* Use of 5 alpha reductance inhibitors
* Plan to father children

Primary outcomes:
measure: Lean body mass
timeFrame: january 2008-january 2010
Secondary outcomes:
measure: Insulin sensitivity, Visceral fat/liver fat, Body fat, Waist, Physical conditions and physical strengths, Adiponectin, Lipid metabolism, Subjective sensation of energy, Urine cortisol, Sexual function, Serum testosterone
timeFrame: january 2008-january 2010
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
name: Marianne Andersen, Md, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruse R, Petersson SJ, Christensen LL, Kristensen JM, Sabaratnam R, Ortenblad N, Andersen M, Hojlund K. Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone. Metabolism. 2020 Nov;112:154347. doi: 10.1016/j.metabol.2020.154347. Epub 2020 Aug 25.
citation: Jensen RC, Christensen LL, Nielsen J, Schroder HD, Kvorning T, Gejl K, Hojlund K, Glintborg D, Andersen M. Mitochondria, glycogen, and lipid droplets in skeletal muscle during testosterone treatment and strength training: a randomized, double-blinded, placebo-controlled trial. Andrology. 2018 Jul;6(4):547-555. doi: 10.1111/andr.12492. Epub 2018 Apr 15.
citation: Glintborg D, Christensen LL, Kvorning T, Larsen R, Brixen K, Hougaard DM, Richelsen B, Bruun JM, Andersen M. Strength training and testosterone treatment have opposing effects on migration inhibitor factor levels in ageing men. Mediators Inflamm. 2013;2013:539156. doi: 10.1155/2013/539156. Epub 2013 Sep 8.
citation: Kvorning T, Christensen LL, Madsen K, Nielsen JL, Gejl KD, Brixen K, Andersen M. Mechanical muscle function and lean body mass during supervised strength training and testosterone therapy in aging men with low-normal testosterone levels. J Am Geriatr Soc. 2013 Jun;61(6):957-962. doi: 10.1111/jgs.12279. Epub 2013 Jun 3.