louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00325546: Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20mg), Multi-National, Multicentre Study of Weight-Reducing Effect and Safety of Rimonabant in Obese Patients With or Without Comorbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-05-15
Enrollment: 643
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: Primary : effect on weight loss and weight maintenance over 9 months when prescribed with a hypocaloric diet in obese patients.

Secondary : effect on HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference - safety and tolerability


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI)\> 25 kg/m²

Exclusion Criteria:

* Absence of stable weight (variation \< 5 kg) within three months prior to screening visit),
* Absence of effective contraceptive method for females of childbearing potential,
* Presence of treated or untreated type 1 or type 2 diabetes,
* Systolic blood pressure \> 165 mm Hg and/or diastolic blood pressure \> 105 mm Hg on 2 consecutive visits from the screening to the inclusion visit,
* Presence of secondary hypertension,
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint (presence of any clinically significant endocrine disease according to the Investigator, obesity of known endocrine origin...)
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study,
* Presence of any clinically significant abnormality according to the Investigator on the ECG performed on the inclusion visit.
* Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
* Related to previous or concomitant medications :

  * Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
  * Antidiabetic drugs.
* Related to laboratory findings:

  * Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
  * Abnormal TSH level (TSH \> ULN or \< LLN).
  * Positive urine pregnancy test.

Primary outcomes:
measure: Absolute change in weight from baseline to month 9
Secondary outcomes:
measure: HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).
Other outcomes:
Locations:
city: Shangai
country: China
facility: Sanofi-Aventis
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis
city: Taipei
country: Taiwan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06188546: Propofol for Prophylaxis of Morphine Induced Pruritis in Caesarean Section
Official title: Administration of Propofol for Prophylaxis of Intrathecal Morphine Induced Pruritus in Caesarean Section
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pruritus Caused by Drug
Keywords: morphine induced pruritus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the goal of this randomized clinical trial is to find the optimum sub hypnotic dose of iv propofol that prevents the incidence of itching induced from intrathecal morphine used in spinal anesthesia in caesarean section operation. the main questions it aim to answer are the number of patients complained of pruritus in the first 24 hours post operative period and the severity of the pruritus. participants will be divided into 4 groups. 1st group receives 0 mg of propofol , 2nd receives 10 mg , 3rd receives 20 mg and the 4th receives 30 mg.


Eligibility criteria: Inclusion Criteria:

1. The study is scheduled for women undergoing elective caesarean section under spinal anesthesia.
2. The subject is ≥ 20 years and ≤ 40 years.
3. No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests.
4. ASA class 1-2.

Exclusion Criteria:

* Patients who had a known allergy to propofol, morphine, or bupivacaine.
* Those with preexisting pruritus caused by pregnancy, a coexisting skin disorder, or other pruritogenic systemic diseases.
* Patients with a contraindication to spinal anaesthesia
* Failed block
* Need of extra sedation intra-operative
* Positive history for asthma or COPD.
* Patient refusal

Primary outcomes:
measure: number of participants complained of pruritus in the first 24hr post operative period
timeFrame: first 24 hours post operative period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Zein Zarea, MD
role: STUDY_CHAIR
affiliation: South Egypt's cancer institute
name: Diab Fuad Hetta, MD
role: STUDY_DIRECTOR
affiliation: South Egypt's cancer institute
name: Rania Mohamed Abdelemam, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04675346: Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors
Official title: Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma, Stage I
Melanoma Stage III
Melanoma, Stage II
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
name: Ninewells Hospital
name: University of Oxford
First posted: 2020-12-19
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the Dermatology or Medical Oncology departments with a confirmed diagnosis of AJCC V8 stage I - III melanoma in the last year

Brief summary: This is a prospective, multi-centred cohort study whereby the EUNASS Study questionnaire will be administered electronically to identify needs of melanoma survivors, the extent to which these needs are being met, and identify areas which have the greatest need for development. It will also evaluate behaviour in relation to sun protection and skin self-examination (SSE). It will be a self-completed questionnaire.

Qualitative work using semi-structured interviews will explore the needs of melanoma survivors in greater depth, will present examples of potential interventions to improve SSE and explore factors that determine the likelihood of engaging in an intervention which can address unmet needs, such as improving SSE. Taken together, the data will provide the evidence base to inform the development of an intervention to improve SSE, which can subsequently be tested in secondary care services.


Eligibility criteria: Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study.

* Male or Female, aged 18 years or above.
* Histological diagnosis of primary cutaneous invasive melanoma (any Breslow thickness) at 3 - 12 months from diagnosis (as most primary treatment will be complete by 3 mths)
* American Joint Cancer Committee Version 8 \[2018\] (AJCC V8) Stage I - III melanoma at time of recruitment
* Able to complete an electronic questionnaire

Exclusion Criteria:

* Other current active internal malignancy (i.e. does not include non-melanoma skin cancers)
* Inability to independently complete electronic questionnaire
* AJCC V8 Stage IV melanoma at time of recruitment
* Clinical stage of disease unknown / unconfirmed

Primary outcomes:
measure: Mixed methods: analysis of a) Patient questionnaire responses and b) Semi-structured interviews
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Headington
country: United Kingdom
facility: Churchill Hospital
state: Oxford
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Rubeta Matin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05918146: Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis
Official title: Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Subdeltoid Bursitis
Injection
Effect of Drug
Keywords: subdeltoid bursitis
dextrose
physical therapy
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.

Detailed description: A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up

Exclusion Criteria:

* history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months

Primary outcomes:
measure: Shoulder pain and disability index
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary outcomes:
measure: Disabilities of the arm, shoulder, and hand
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
measure: Visual analog scale
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
measure: range of motion
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01626846: How Neurofibromatosis Type 1 (NF1) Affects Schoolwork and Self-Esteem
Official title: Cognitive Impairments, Self-Esteem & Academic Performance in Teenagers With Neurofibromatosis Type 1
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurofibromatosis Type 1
Keywords: Neurofibromatosis
Lead sponsor: John Jay High School
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teenagers aged 14-17 years with NF1

Brief summary: The study will seek to determine whether there is a corresponding deficit in school performance for teenagers with NF1. Secondly, the study seeks to explore the issue of self-esteem in teenagers with NF1.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Neurofibromatosis Type 1

Exclusion Criteria:

* Neurofibromatosis Type 2
* Schwannomatosis

Primary outcomes:
measure: Evidence of effect on self-esteem evidenced by self-esteem scores
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cross River
country: United States
facility: John Jay High School
state: New York
Study officials:
affiliation: Westchester Community College
name: Eileen Karlik, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04519346: Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache
Official title: Comparison of Intradermal Mesotherapy With Systemic Therapy in the Treatment of Migraine Headache: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headache
Keywords: Mesotherapy
Migraine
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 150
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: Introduction:Migraine is a prevalent disabling primary headache disorder which is classified in two major types; migraine without aura and migraine with aura. The aim of this study was to compare the efficiency of mesotherapy with systemic therapy in pain controlin patients with headache related tomigraine without aura.

Methods: We conducted this prospective parallel randomized controlled trial with the patients admitted to the emergency department with headache related to migraine without aura. One group was treated with mesotherapy, and the control group with intravenous dexketoprofen. Changes in pain intensity at 30th minute, 60th minute, 120th minute and 24th hours after treatment using Visual Analogue Scale (VAS), need to use analgesic drug within 24 hours,re-admission with same complaint to emergency department (ED) within 72 hours, and adverse effect rate of the methods were compared between groups.


Eligibility criteria: Inclusion Criteria:

* 18 years and older age, and (2)
* Admission to Emergency Department (ED) with headache related to the migraine without aura.

Exclusion Criteria:

* Taking analgesic drugs before admission,
* Having VAS score of lower than 4 on admission,
* Having diabetes mellitus,
* Body mass index\>30 kg/m2,
* Pregnancy,
* Lactation,
* Having active bleeding or bleeding disorder,
* Having active or recurrent gastrointestinal hemorrhage or ulcer, or history of these conditions,
* Having a serious or life-threatening condition (stroke, intracranial hemorrhage, heart attack, cardiac tamponade, pneumothorax, hemothorax, flail chest, etc.).

Primary outcomes:
measure: change in headache intensity
timeFrame: 0-24 hours
measure: need to use analgesics within 24 hours after treatment
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Akbas I, Kocak MB, Kocak AO, Gur STA, Dogruyol S, Demir M, Cakir Z. Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial. Ann Saudi Med. 2021 May-Jun;41(3):127-134. doi: 10.5144/0256-4947.2021.127. Epub 2021 Jun 1.
Clinical trial NCT04073446: Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
Official title: Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Spinal Cord Stimulation
Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 3
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: To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.


Eligibility criteria: Key Inclusion Criteria:

* Average unilateral foot, or knee or groin pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score
* Subject signed a valid, EC-approved informed consent form (ICF)
* Willing and able to comply with all protocol-required procedures and assessments/evaluations
* 18 years of age or older when written informed consent is obtained

Key Exclusion Criteria:

* Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
affiliation: Boston Scientific Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References:
Clinical trial NCT00529646: Single-Dose Safety Study of APD791 in Healthy Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability, Pharmacokinetics, and Pharmacodynamics of APD791 Administered to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy adult volunteers
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women, ages 19-45
* Non smokers

Exclusion Criteria:

* History of a bleeding disorder
* Recently donated blood or had significant blood loss
* Current use of a prescription medication
* Pregnant females

Primary outcomes:
measure: Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters
Secondary outcomes:
measure: Pharmacokinetic and pharmacodynamic assessments
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services
state: Nebraska
Study officials:
affiliation: Arena Pharmaceuticals
name: Christen Anderson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04284046: CT Scores Predict Mortality in 2019-nCoV Pneumonia
Official title: CT Scores Predict Mortality in 2019-nCoV Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CT Scores Predict Mortality in 2019-nCoV Pneumonia
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients suspected of 2019 novel coronavirus infection.

Brief summary: While 2019-nCoV nucleic acid swab tests has high false positives rate, How to diagnose 2019-nCoV pneumonia and predict prognosis by CT is very important.In this retrospective single-center study, we consecutively included suspected 2019-nCoV pneumonia critical cases in the intensive care unit of Wuhan third hospital from January 31, 2020 to February 16, 2020. The cases were confirmed by real-time RT-PCR, and all patients were evaluated with CT, cutoff values were obtained according to the Yoden index, and were divided into high CT score group and low CT score group. Epidemiological, demographic, clinical, and laboratory data were collected.


Eligibility criteria: Inclusion Criteria:

* all patients suspected of 2019 novel coronavirus infection.

Exclusion Criteria:

* patients' data are not available.

Primary outcomes:
measure: 7-day mortality
timeFrame: 7-day
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan third hospital
state: Hubei
Study officials:
References:
Clinical trial NCT06044246: Influence of Human Platelet Derivatives on Dental Implant
Official title: Influence of Human Platelet Derivatives on Dental Implant Osseointegration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Platelet-Rich Fibrin
Dental Implantation
Bone Substitute
Keywords: Dental implant
PRF
membrane
osseointegration
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to evaluate the benefit of PRF membrane on bone around dental implant in patients who need treatment with dental implant.

Aims of the study:

* To study the effect of PRF membrane (with or without bone substitute on increasing bone dimension around dental implant.
* To investigate the effects of compositions of PRF (platelets count, WBC count) on bone healing.

Detailed description: Materials and methods:

PRF will be obtained from a blood sample that is taken from the patient at the time of surgery in 10-mL tubes, the blood-containing tube is placed in a centrifuge at specially controlled rotations, temperature and time. The result is the separation of blood, basically from two by-products, including PRF. The PRF clot will be placed in specific box ( P.R.F -System; Surgident, CE ) to create a PRF membrane with specific thickness that will be placed on the bone around dental implant.

Evaluation of the results

* Alveolar bone width around dental implant will be measured.
* Histological examination of the tissue that excised during dental implant uncover surgery.
* Evaluate pain by visual analogue score (VAS).
* Estimate the count of WBC and platelets in whole blood will be obtained from a laboratory results.

Eligibility criteria: IInclusion criteria

* Non- smoker.
* No medical history of any systemic diseases that affect the bone metabolism.
* Did not receive any systemic drugs.
* Has edentulous area that needs dental implant.

The exclusion criteria were as follows:

* Systemic disease or medication compromising bone and soft tissue healing.
* Pathology in the edentulous region.
* Bruxism.
* Disease of the oral mucosa.

Primary outcomes:
measure: Osseointegration
timeFrame: Immediately after surgery, after 12 weeks (during uncover implant surgery)
measure: Bone width
timeFrame: Baseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Kadhimiya Teaching HospitalKadhimiya Educational Hospital
state: Alkadhmiya City
Study officials:
affiliation: College of Dentistry, Mustansiriyah University.
name: Assis. Prof. Dr. Afya SD Al-radha
role: PRINCIPAL_INVESTIGATOR
References: