louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01909856: The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
Official title: The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;
* The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;
* Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;
* Life expectancy ≥ 3 months;
* Adequate hematologic function;
* Adequate hepatic function;
* Adequate renal function;
* At least 2 weeks away from the last chemotherapy;
* Patients signed written informed consent.

Exclusion Criteria:

* Pregnant or lactating women;
* History of anticipatory vomiting;
* Radiation therapy on the abdomen or pelvis within one week prior to study entry;
* Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);
* Patients with gastrointestinal obstruction;
* Patients with severe heart disease, liver or renal disease, or metabolism disorders;
* Patients with epilepsy or using sedative or psychotropic drugs;
* Patients with diabetes or with contraindication for corticosteroids;
* Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;
* Patients with brain metastasis or intracranial hypertension;
* Hypersensitivity to 5-HT3 receptor antagonist;
* Patients with active infection;
* Other conditions that the investigator considered as unsuitable for chemotherapy;
* Subjects participating in other clinical trials.

Primary outcomes:
measure: Complete Response(CR) within 24-120 hours after chemotherapy
timeFrame: 24-120 hours
Secondary outcomes:
measure: CR within 0-120 hours after chemotherapy
timeFrame: 0-120 hours
measure: CR within 0-24 hours after chemotherapy
timeFrame: 0-24 hours
measure: Incidence of Adverse events
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Shiying Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02535156: Schizotypal Personality Disorder Risperidone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizotypal Personality Disorder
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Neurophysiological indices of self-monitoring were assessed in a group of patients with Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after the administration of risperidone and placebo.

Detailed description: The electroencephalogram (EEG) was recorder while participants (SPD participants and controls) performed a behavioral task: the Eriksen Flanker Task. The continuous EEG was segmented, corrected for artifacts and averaged. A component of the event-related brain potential known as the error-related negativity (ERN) was identified and its amplitude quantified in microvolts.

This procedure was conducted two hours after the administration of risperidone 1 mg and placebo (lactose) on two different experimental days and for each participant group (SPD patients and controls).

The amplitude of the ERN after placebo was compared between groups to test for baseline (non-drug-induced) differences between patients and controls.

The impact of risperidone on the amplitude of the ERN was compared between the two participant groups.

Eligibility criteria: Inclusion Criteria:

* Schizotypal Personality Disorder

Exclusion Criteria:

* Major Psychiatric Disorder
* Medical condition

Primary outcomes:
measure: Neurophysiological indices of self-monitoring (Error Related Negativity)
timeFrame: During acute effects of pharmacological treatment (up to 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05945056: Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis
Official title: Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Postural
Keywords: Low Back Pain
Frog Leg Technique
Exercise Therapy
Lead sponsor: Health Education Research Foundation (HERF)
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Condition in which lumbar region experiences stress or extra weight and is arched to point of muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the effectiveness of frog leg technique and standard exercise therapy in management of low back pain due to lumbar lordosis.

Detailed description: In adult population, a major health problem is Low back pain. Postural change is one of the risk factor. Abnormal posture causes strain on ligaments and muscles, as a result indirectly affects the curvature of the lumbar spine.Condition in which lumbar region experiences stress or extra weight and is arched to point of muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the effectiveness of frog leg technique and standard exercise therapy in management of low back pain due to lumbar lordosis.

Eligibility criteria: Inclusion Criteria:

* Females with age between 20 and 45 years
* Patients with low back ache due to lumbar lordosis

Exclusion Criteria:

* History of surgery
* Patients with discogenic backache.
* Backache in pregnancy.
* Patients with traumatic history.
* Patients with pain due to any reason other than lumbar lordosis.

Primary outcomes:
measure: Change in Pain
timeFrame: Data was Collected at Baseline, 5th Day & 10th Day.
measure: Change in Disability Level
timeFrame: Data was Collected at Baseline, 5th Day & 10th Day.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bashir Institute of Health Sciences
name: Anam Javed, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04390256: Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers
Official title: Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate:

1. The remineralization potential of natural agents (egg shell powder and clove extract) versus bioadhesive polymers (carbopol and carboxymethyl cellulose) with or without PH cycling using microhardness test.
2. The clinical efficacy of all agents in patients with early carious lesions.


Eligibility criteria: Inclusion Criteria:

* 1. Criteria related to patient:

  * Age's eligible for trial was 18- 30 years.
  * Patient able to read and sign the informed consent form.
  * Cooperative patient who are willing to participate and able to continue the schedule time of wok keep good oral hygiene throughout the study.
  * Healthy volunteers.
  * Patient with moderate and high caries index. 2. Criteria related to tooth:
  * Patient with at least 2 white lesions (WSL) detected clinically on the buccal surface of permanent anterior teeth, one on each side. WSL selected either due to caries or orthodontic treatment (just following deboning).
  * Teeth with score1, 2, 3 according to ICDAS II.
  * Absence of preoperative pain, no mobility \& tenderness on percussion.
  * Radiographically, the pre-operative inclusion criteria were absence of internal or external resorption, no periapical radiolucencies and no widening of periodontal ligament space..

Exclusion Criteria:

* 1. Criteria related to patient:

  * Patient with Rampant uncontrolled caries.
  * Patient with compromised medical history.
  * Pregnant or breast feeding females.
  * Heavy smoker.
  * Patient who currently received extensive fluoride regiments for treatment of WSL.
  * Patients who planned to move within 3 months of enrollment.
  * Patient with evidence of xerostomia. 2. Criteria related to tooth:
  * Teeth with score 4, 5 according to ICDAS II.
  * Teeth with periapical pathology, internal or external resorption or exhibiting any symptoms of pulp pathology.
  * Teeth with questionable vitality or have root canal therapy.
  * Teeth have been pulp capped.
  * Teeth with periodontal pocket and bleeding on probing.
  * Cracked teeth.

Primary outcomes:
measure: Remineralization of enamel
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar university
Study officials:
References:
Clinical trial NCT04739956: Psychological Impact of Pregnancy of Unknown Location
Official title: Psychological Impact of Pregnancy of Unknown Location
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy of Unknown Location
Ectopic Pregnancy
Anxiety
Keywords: Pregnancy of unknown location
PUL
Ectopic pregnancy
Anxiety
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2021-02-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women attending the Early Pregnancy Unit in the first trimester (up to 14 weeks gestation) with a pregnancy of unknown who are over 18 years old and are able to give consent.

Brief summary: To assess the psychological impact of pregnancy of unknown location (PUL) classification pending a final diagnosis.

Detailed description: PUL is a syndrome of early pregnancy composed of a positive urine pregnancy test without the visualisation of a pregnancy on trans-vaginal ultrasound (TVUS). The current method for risk stratifying a PUL is via serum BhCG levels at the time of identification of PUL and after 48 hours, in order to ascertain the viability of the pregnancy. Patients and their partners need to wait for this result before a management plan can be adopted, taking at least 2-3 hours. There is a clear need for the patient care pathway to evolve in order to aid and improve the management of women classified with a PUL. By using point-of-care BhCG testing, the investigators hope to shorten the time to management. The investigators therefore propose that shortening the time interval would reduce psychological morbidity. This is a prospective cohort observational study.

Eligibility criteria: Inclusion Criteria:

* Pregnant women attending the Early Pregnancy Unit in the first trimester (up to 14 weeks gestation) with a pregnancy of unknown who are over 18 years old and are able to give consent.

Exclusion Criteria:

* Presence diagnosed with cancer
* The presence of an acute medical condition
* Patients/partners aged less than 18 years
* Patients or partners who cannot give fully informed study consent (language or learning impairment)
* Presence of a viable intrauterine pregnancy, ectopic pregnancy and miscarriage.

Primary outcomes:
measure: Psychological Morbidity
timeFrame: 0 hours, 48 hours and point of diagnosis (within 2 wees)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References:
Clinical trial NCT06628856: Quality of Life of the Piloted Individuals and a Cost-efficiency Analysis
Official title: Ex Ante and Interim Evaluation of the Quality of Life of the Piloted Persons, and Cost-efficiency Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Terminal Illness
Keywords: Person-centred care
meaningful activities
direct care professional
occupational therapist
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 166
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The increasing life expectancy and global aging population necessitate changes in long-term gerontological services based on Person-Centred Care approaches. This study aims to improve Person-Centred Care in geriatric centers through meaningful activities and the role of occupational therapists and direct care professionals in developing these activities. A descriptive cross-sectional quasi-experimental design was proposed, with 10 participants.

Detailed description: Background: Increasing life expectancy means that the ageing of populations globally is on the rise. It is therefore important to promote changes in long-term gerontological services based on Person-Centred Care approaches, in which meaningful occupation serves as a basis and is supported by appropriate professional support, such as the occupational therapist and the direct care professional.

Objective: The study aims to analyze the needs, quality of life, and coping strategies of terminally ill patients over five months, as well as burnout and dehumanization among caregivers and healthcare staff.

Methods: This study examines factors influencing the quality of life (QOL) of terminally ill patients and the burnout and dehumanization of caregivers and health professionals using a mixed methodology. The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being.

Eligibility criteria: Inclusion Criteria:

* That the direct care worker has a degree as a nursing assistant, dependency care technician, geroculturist or certificate of professionalism.
* The worker must speak and understand Spanish.
* The residence must offer service during the day, in the morning or afternoon shift.
* Workers must have been with the department for more than 4 months.

Exclusion Criteria:

* Workers who work night shift only.
* Workers on rotating shifts in all departments of the residence.
* Workers absent at the time of the study due to temporary leave, vacations or other causes.

Primary outcomes:
measure: Qualitative analysis
timeFrame: 5 MONTHS
measure: Multilevel analysis
timeFrame: 5 MONTHS
measure: Student's t-tests
timeFrame: 5 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Olalla Saiz Vazquez
Study officials:
References:
Clinical trial NCT01289756: Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Official title: Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anovulation
Disorder Due Cytochrome P450 CYP2D6 Variant
Cytochrome P450 CYP3A Enzyme Deficiency
Keywords: pharmacokinetic
clomiphene
CYP2D6 polymorphisms
inhibition of CYP2D6 and CYP3A4
Lead sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Female caucasians
* Age 18 - 45 years old
* BMI 18.5 - 26 kg/m2

Exclusion Criteria:

* Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin
* Pregnancy/lactation period
* Meno-/postmenopausal
* Smokers

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)of clomiphene
timeFrame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application
measure: Peak Plasma Concentration (Cmax)of Clomiphene
timeFrame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application
Secondary outcomes:
measure: Clearance of Clomiphene
timeFrame: 4, 8, 12 and 24 hours after drug application
measure: Metabolomic
timeFrame: 4, 8, 12 and 24 hours after drug application
measure: Tmax of clomiphene
timeFrame: 4, 8, 12, 24 hours after drug application
measure: Pharmacogenomics
timeFrame: once
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen
state: BW
Study officials:
affiliation: Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
name: Matthias Schwab, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04953156: Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension
Official title: A Comparative Study Between Nitroglycerine Infusion and Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia

Brief summary: This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative elevation of blood pressure.

Detailed description: Nitroglycerine is a direct vessel wall vasodilator with more venodilator effect than arterial dilator effect. It is used as an anti-anginal and antihypertensive drug. On the other hand, dexmedetomidine is a highly selective alpha 2 adrenergic agonist with sympatholytic effect. This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative elevation of blood pressure.

Eligibility criteria: Inclusion Criteria:

* Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia
* ≥ Age 18 years.

Exclusion Criteria:

* patient refusal
* patients on Beta blockers
* kidney or liver function impairment
* bradycardia, any degree of heart block and severe cardiorespiratory disease

Primary outcomes:
measure: Intraoperative blood pressure values
timeFrame: Intraoperative period
Secondary outcomes:
measure: Intraoperative heart rate values
timeFrame: operative time
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03220256: Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients
Official title: Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lamotrigine Allergy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators intend to find a way to lower drug rash occurrence by applying drug tolerance induction protocol at the beginning of lamotrigine administration.

Genotyping of participants with rash and those without rash after taking lamotrigine and genetic testing to find common gene mutations in these participants.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-85 years old
* Epilepsy patients
* Patients who started Lamotrigine first time

Exclusion Criteria:

* Those who do not agree with prior consent
* Women taking oral contraceptives.
* history of drug rash
* Taking enzyme-inducing antiepileptic drugs (EIAED) or valproate (VPA)

Primary outcomes:
measure: Skin rash incidence rate
timeFrame: 2 weeks
Secondary outcomes:
measure: Changes in Treg cell ratio in peripheral blood
timeFrame: 2 weeks
measure: Severity of skin rash (CTCAE version 4.0)
timeFrame: 2 weeks
measure: Lamotrigine drug level in blood (mcg/ml)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Wang XQ, Xiong J, Xu WH, Yu SY, Huang XS, Zhang JT, Tian CL, Huang DH, Jia WQ, Lang SY. Risk of a lamotrigine-related skin rash: current meta-analysis and postmarketing cohort analysis. Seizure. 2015 Feb;25:52-61. doi: 10.1016/j.seizure.2014.12.001. Epub 2014 Dec 23.
citation: Murray TS, Rice TW, Wheeler AP, Phillips EJ, Dworski RT, Stollings JL. Medication Desensitization: Characterization of Outcomes and Risk Factors for Reactions. Ann Pharmacother. 2016 Mar;50(3):203-8. doi: 10.1177/1060028015625660. Epub 2016 Jan 18.
citation: Castells M. Desensitization for drug allergy. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):476-81. doi: 10.1097/ACI.0b013e3280108716.
citation: Akdis CA. Therapies for allergic inflammation: refining strategies to induce tolerance. Nat Med. 2012 May 4;18(5):736-49. doi: 10.1038/nm.2754.