louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06622941: Study to ONO-4538 in Patients With Rhabdoid Tumor
Official title: A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rhabdoid Tumor
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 23
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors


Eligibility criteria: Inclusion Criteria:

1. Gender: Not specified
2. Age (at the time of consent): 1 year or older
3. Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors
4. Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection

Exclusion Criteria:

1. Patients with a history of active concurrent malignancy or complications
2. Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period
3. Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 4.5 years
Secondary outcomes:
measure: Objective response rate (ORR) (site investigator assesment)
timeFrame: up to 4.5 years
measure: Overall survival (OS)
timeFrame: up to 4.5 years
measure: Progression free survival (PFS)
timeFrame: up to 4.5 years
measure: Disease control rate (DCR)
timeFrame: up to 4.5 years
measure: Time to response (TTR)
timeFrame: up to 4.5 years
measure: Best overall response (BOR)
timeFrame: up to 4.5 years
measure: Percent change from baseline in the sum of diameters of target lesions
timeFrame: up to 4.5 years
measure: Best reduction percent change from baseline in the sum of diameters of target lesions
timeFrame: up to 4.5 years
measure: Incidence of Adverse Events [Safety]
timeFrame: Up to 30 days after the last dose
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Osaka City General Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT06032741: Prognosis in Patients With Guillain-Barre Syndrome
Official title: Prognosis in Patients With Guillain-Barre Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Guillain-Barre Syndrome
Keywords: Guillain-Barre Syndrome
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.

Brief summary: The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.

Detailed description: This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.

Eligibility criteria: Inclusion Criteria:

* patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.

Exclusion Criteria:

* nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome

Primary outcomes:
measure: the severity of Guillain-barre syndrome
timeFrame: baseline, at 1 week, at 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01406041: Disturbance of Water and Sodium Metabolism After Surgery of Sellar Lesions, and Correspond Clinical Strategy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Patients Suffered With Sellar Diseases
The Fluid and Electrolyte Imbalance Happened After Surgery
Keywords: Fluid and electrolyte imbalance
Hyponatremia
Hypernatremia
Electrolytes disorder
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presented in our department suffered with sellar diseases

Brief summary: The fluid and electrolyte imbalance (FEI) is pretty common encountered during the clinical process of patients suffered sellar lesions. Moreover, if the patients are undergone the surgery for remove the lesion, FEI happens in all cases without exception. Hypo- and hyper-natremia is the most common electrolyte disorder, which is directly correlated to the patients' outcome. However, in clinical works, different sellar diseases cause variant features of FEI. For example, after the surgery of craniopharyngioma, the hyponatremia and hypernatremia always happen alternatively even without any precursor manifestation. Under this situation, it is quite difficult for fluid supplement. In contrast, the severe FEI will cause poor outcome, even death. So it is necessary to systematically collect and review the clinical data of sellar lesions. Through the analysis of variant FEI patterns of sellar diseases, more precise strategy for clinical fluid replacement will be proposed.


Eligibility criteria: Inclusion Criteria:

* 1. Suffered with sellar disease
* 2. Udergone surgery
* 3. Have sufficient presurgical and postsurgical clinical data (Including MRI, CT, physical and chemical detection results)

Exclusion Criteria:

* 1. Without sufficitent clincal data
* 2. No surgery

Primary outcomes:
measure: Blood sodium
timeFrame: 24 hours
Secondary outcomes:
measure: Urine sodium
timeFrame: 48 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The department of Neurosurgery, Nanfang hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00518141: Use of Acetyl Salicylic Acid and Terbutalin in Assisted Reproductive Techniques (ART)
Official title: Use of Acetylsalicylic Acid and Terbutalin in ART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Techniques, Assisted
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
First posted: 2007-08-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and Terbutalin on ART treatment.

Detailed description: This study aims to determine the possible effects of ASA and Terbutalin on ART treatment.

Eligibility criteria: Inclusion Criteria:

* Infertile women below 39 years of age

Exclusion Criteria:

* Women who may react allergically to the drugs administered
* Women with hyperthyroid or IDDM
* Women who do not want to participate in the study
* Women who are unable to give informed, written consent.

Primary outcomes:
measure: Pregnancy
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porsgrunn
country: Norway
facility: STHF, Kvinneklinikken, Fertilitetsklinikken Sor
state: Telemark
Study officials:
affiliation: STHF, Kvinneklinikken, Fertilitetsklinikken Sor
name: Jarl A Kahn, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05560919: Acceleration of Orthodontic Tooth Movement
Official title: Evaluation of Clinical Efficacy of Locally Injected Vitamin D3 (Calcitriol or 1,25 Dihidroxicolecalciferol) in Accelerating Orthodontic Tooth Movement (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mild to Moderate Anterior Mandibular Segment Crowdind
Keywords: Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, A randomized, controlled, parallel, double-blind clinical study
Primary purpose: TREATMENT

Brief summary: EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25 dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized, controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25 years old.

Detailed description: The rate of orthodontic tooth movement depends on two general factors: the forces used in order to cause orthodontic tooth movement and respectively the individual (biological) response of the body to these forces.

There are many methods for accelerating orthodontic tooth movement. but, every method has its disadvantages, such as pain and root absorption. Locally injected of vitamin d3 was proposed to accelerates tooth movement with minimal disadvantages, but there aren't enough clinical studies to prove this claim.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate crowding of mandible teeth. In accordance with LITTLE'S IRREGULARITY INDEX
* Healthy patient
* No previous orthodontic treatment
* Vital teeth with periodental tissue without root absorption,

Exclusion Criteria:

* Previous history of orthodontic or orthopedic treatment.
* Presence of craniofacial anomalies.
* Presence of any signs and symptoms of gingival and periodontal diseases.
* Presence of significant medical history (including drug allergy).
* Pregnant and lactating women.

Primary outcomes:
measure: Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch
timeFrame: 6 months
Secondary outcomes:
measure: Second Outcome Measure was leveling and alignment improvement percentage (LAIP) of the Mandible teeth throughout the leveling and alignment stage.
timeFrame: 6 months
measure: VAS scale
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University - Faculty of dentistry
Study officials:
References:
Clinical trial NCT00598819: A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
Official title: A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebral Ischemia
Keywords: Cerebral Oxygenation
Oxygen Monitoring
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether a new cerebral oxygen monitoring device is effective and comparatively similar to the current approved devices.

Detailed description: Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their effectivity.

Eligibility criteria: INCLUSION CRITERIA:

* Healthy male or Female Volunteers
* 18 years old or older
* Capable and willing to operate a bicycle
* Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study

EXLUSION CRITERIA:

* History of Cerebrovascular Disease
* History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.)
* Pregnancy

Primary outcomes:
measure: Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.
timeFrame: attachment of sensor to 24 hours post-removal
measure: Overheating of Skin Underneath Sensor.
timeFrame: placement of sensor to 10 minutes post-removal.
measure: Overheating of Skin Underneath Sensor
timeFrame: placement of sensor to immediately post-removal
Secondary outcomes:
measure: Sensor Fits Well on Subjects Forehead
timeFrame: placement of sensor to end of study observation
measure: Sensor Attachment Under Stress
timeFrame: addition of stress on sensor to removal.
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Jeffrey C Milliken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188019: Hereditary Paraganglioma: Evaluation of Screening Methods to Detect Tumors in SDH Positive Carriers
Official title: Evaluation Des méthodes de dépistage du Paragangliome héréditaire Chez Les Sujets prédisposés génétiquement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraganglioma
Pheochromocytoma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2005-09-16
Enrollment: 248
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hereditary paraganglioma -due to SDH (SDHD, SDHB, SDHC) germline mutations- causes paragangliomas and pheochromocytomas. Presymptomatic genetic testing should be offered to all first-degree relatives if an SDH mutation is detected in an index case with paraganglioma or pheochromocytoma. The main objective of our national clinical research project is to test different screening methods to detect presymptomatic tumors in order to establish guidelines for the work-up and the follow-up of SDH mutation carriers.


Eligibility criteria: Inclusion Criteria: identification of an SDH (SDHD, SDHD, SDHC) germline mutation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Européen Georges Pompidou Hospital
Study officials:
affiliation: University Angers Hospital
name: Vincent Rohmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Paris-Descartes University, Européen Georges Pompidou Hospital, Assistance Publique des Hôpitaux de Paris
name: Anne-Paule Gimenez-Roqueplo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02193919: A Single-Center, Prospective, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
Official title: A Single-Center, Prospective, Single-Blind, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: psoriasis
Lead sponsor: Bagel, Jerry, M.D.
Sponsor class: INDIV
First posted: 2014-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients, males, females, over 18 yo with moderate-to-severe psoriasis

Brief summary: Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments may help even more. Determining if a high protein diet vs a low protein diet results in improving psoriais may help lead to future dietary effects on psoriasis therapy


Eligibility criteria: Inclusion Criteria:

* PSA greater 10
* BMI greater than 30

Exclusion Criteria:

* PSA less than 10
* less than 18 years old

Primary outcomes:
measure: Does weight decrease the amount of UVB needed to clear psoriasis
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Psoriasis Treatment Center of Central New Jersey
name: Jerry Bagel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06490419: Effect of Ultrasound Cavitation Versus Electrolipolysis on Obese Infertile Women With Polycystic Ovarian Syndrome
Official title: Effect of Ultrasound Cavitation Versus Electrolipolysis on Obese Infertile Women With Polycystic Ovarian Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the difference between the effect of ultrasound cavitation and electrolipolysis on obese infertile women with polycystic ovarian syndrome.

Detailed description: Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy among women during reproductive age . PCOS affects 5-10% of women in reproductive age. It has an effect on quality of life , fertility and pregnancy.

Obesity plays a significant role in reproductive disorders, particularly in women. It is associated with anovulation, menstrual disorders, infertility, difficulties in assisted reproduction, miscarriage, and adverse pregnancy outcomes.

The treatment of obesity and infertility causes some harm to women, due to the danger of some operations and medications other than the high cost of these operations, so it is necessary to use a therapeutic alternative that is non invasive, with lower risk and lower cost.

Both ultrasound cavitation (UC) and electrolipolysis are non invasive modalities with many positive effects on obesity and PCOS outcomes. The effect of both the UC and electrolipolysis has been separately investigated in previous studies. Though, no studies were found to compare the effect of both modalities in the management of infertile women with PCOS. Therefore, this study will be conducted to explore the effect of UC versus electrolipolysis on infertile women with PCOS.

Eligibility criteria: Inclusion Criteria:

* Infertile married PCOS women, diagnosed by Rotterdam criteria .
* Their ages will be ranged between 25-35 year old.
* Their BMI will be ranged from 30-40 kg/ m2.
* Their waist/hip ratio equal to or more than 0.85

Exclusion Criteria:

* Thyroid dysfunction (hypothyroidism).
* Chronic and/or systemic illnesses (e.g. diabetes mellitus, liver, renal respiratory failure and cardiovascular disorders).
* Malignant tumors.
* Tubal adhesions as well as uterine abnormalities.
* Skin diseases in the abdominal and gluteal regions.
* Conditions that may prevent the use of electrical stimulation.

Primary outcomes:
measure: Weight, height and BMI measurements
timeFrame: within 3 months
measure: Waist hip Ratio
timeFrame: within 3 months
measure: LH/ FSH Ratio
timeFrame: within 3 months
measure: Ovulation rate
timeFrame: within 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Afaf Botla, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04558619: Exploring the Feasibility of Kōmmour Prenatal to Reduce Maternal and Infant Health Disparities
Official title: Exploring the Feasibility of a Group Prenatal Program, Kōmmour Prenatal, to Reduce Maternal and Infant Health Disparities Among Marshallese Pacific Islander Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kōmmour Prenatal Among Marshallese Pregnant Women
Keywords: Kōmmour
Prenatal
Marshallese
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to culturally adapt and examine the feasibility of a group prenatal program (Kōmmour Prenatal) to reduce maternal and infant health disparities among Marshallese Pacific Islander women in the US. The study will also gather information from providers of Kōmmour Prenatal and stakeholders in the Marshallese community familiar with the program to learn of their experience with the program.


Eligibility criteria: Inclusion Criteria

* Women who self-identify as Marshallese
* 18 years of age or older
* And 8-20 weeks pregnant

Exclusion Criteria

* Women who do not self-identify as Marshallese
* Not 18 years of age or older
* And not 8-20 weeks pregnant

Primary outcomes:
measure: Gestational Weight Gain
timeFrame: 9 months
Secondary outcomes:
measure: Breastfeeding initiation, birth weight of infant, preeclampsia, primary cesarean birth, and gestational diabetes mellitus
timeFrame: 9 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
affiliation: University of Arkansas for Medical Sciences Northwest
name: Britni Ayers, PhD
role: PRINCIPAL_INVESTIGATOR
References: