louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05697536: Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and QOL in PMS
Official title: Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and Quality of Life in Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The significance of this study is that it may improve the premenstrual symptoms like pain and anxiety in females with premenstrual syndrome and improve their quality of life. This study may add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative choice of therapy. Therefore, the study will be done to compare the effects of Pilate exercises and aerobic exercises on pain, anxiety and quality of life in females with premenstrual syndrome.


Eligibility criteria: Inclusion Criteria:

* Unmarried
* Age between 18-30 years
* Patients with at least 5 of 11 symptoms on premenstrual syndrome questionnaire

Exclusion Criteria:

* Patients suffering from Any Disability.
* Patients suffering from diabetes or hypertension or any other Chronic Illness.
* Spine fracture or history of Any Previous Surgery.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 8th week
measure: Anxiety
timeFrame: 8th week
measure: WHO quality of life questionnaire
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International university, Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Adeela Arif, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.
citation: Samadi Z, Taghian F, Valiani M. The effects of 8 weeks of regular aerobic exercise on the symptoms of premenstrual syndrome in non-athlete girls. Iran J Nurs Midwifery Res. 2013 Jan;18(1):14-9.
citation: Citil ET, Kaya N. Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study. Complement Ther Med. 2021 Mar;57:102623. doi: 10.1016/j.ctim.2020.102623. Epub 2020 Nov 24.
citation: Roh SY. Effect of a 16-week Pilates exercise program on the ego resiliency and depression in elderly women. J Exerc Rehabil. 2016 Oct 31;12(5):494-498. doi: 10.12965/jer.1632704.352. eCollection 2016 Oct.
Clinical trial NCT04658836: Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF
Official title: Triamcinolone Acetonide Levels in Cochlear Perilymph, Lateral Canal and CSF in Patients With Vestibular Schwannomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vestibular Schwannoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients undergoing surgery of a vestibular schwannoma will be included in the study. Patients will receive triamcinolone acetonide 24h before surgery. During translabyrinthine surgery cochlear perilymph, perilymph from the semicircular canal and cerebrospinal fluid will be taken and analyzed for triamcinolone content. In patients undergoing middle fossa or retrosigmoid resection only cerebrospinal fluid will be taken and analyzed for triamcinolone acetonide level.

Detailed description: Patients between 18 and 90 years undergoing surgery of a vestibular schwannoma will be included in the study. Patients will be offered an application of triamcinolone acetonide intratympanically on the day before surgery.

During surgery samples will be taken to define how much triamcinolone acetonide enters into the perilymphatic fluid, the perilymph of the semicircular canals and CSF.

Patients undergoing translabyrinthine surgery will undergoing labyrinthectomy during which samples of the semicircular canal can be taken. During translabyrinthine surgery nerve monitoring will be carried out using an intracochlear electrode. Before inserting the electrode perilymph of the cochlea can be taken. Immediately after opening the dura cerebrospinal fluid will be taken. Patients undergoing middle fossa or retrosigmoid resection of the vestibular schwannoma will not undergo sampling of the perilymph. In these patients cerebrospinal fluid will be taken to determine triamcinolone acetonide levels.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 90 years undergoing a surgery of the cerebellopontine angle due to vestibular schwannoma and who are willing to participate in the study

Exclusion Criteria:

* Patients younger than 18 years Patients who receive cortison regularly or receive cortison i.v. or p.o. preoperatively Patients with contraindications against the administration of VolonâA

Primary outcomes:
measure: Triamcinolone acetonide level
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna (AKH)
Study officials:
affiliation: Medical University of Vienna, Otorhinolaryngology, Head and Neck Surgery
name: Christoph Arnoldner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01334736: A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
Official title: A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: smoking cessation
contingency management
spirometry
lung age
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Thoracic Society
First posted: 2011-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases. Quitting smoking is proven to improve the health of people addicted to cigarettes. . Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking. Additionally, most programs designed to help people quit smoking are not very successful. One reason these programs may not work well is because it is difficult to motivate people to quit smoking. New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results. For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old". In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking. The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.


Eligibility criteria: Inclusion Criteria:

* Active smoker

Exclusion Criteria:

* Enrollment in smoking cessation protocol
* Current use of nicotine replacement therapy

Primary outcomes:
measure: Biologically confirmed tobacco cessation
timeFrame: 6 months
Secondary outcomes:
measure: Self efficacy and intention to quit
timeFrame: 6 months
measure: Cessation attempts
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins ALIVE Clinic
state: Maryland
Study officials:
References:
citation: Drummond MB, Astemborski J, Lambert AA, Goldberg S, Stitzer ML, Merlo CA, Rand CS, Wise RA, Kirk GD. A randomized study of contingency management and spirometric lung age for motivating smoking cessation among injection drug users. BMC Public Health. 2014 Jul 28;14:761. doi: 10.1186/1471-2458-14-761.
Clinical trial NCT02078336: Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
Official title: Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Dental Care for Disabled
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 40
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: The study aims to compare procedural sedation protocols, specifically applied for the delivery of regular dental care in persons with a mental disability.

The primary objectives are:

* To assess the level of cooperation during regular dental care using different procedural sedation protocols
* To assess patient safety during regular dental care using different sedation protocols
* To assess patient comfort and possible side-effects after regular dental care using different sedation protocols


Eligibility criteria: Inclusion Criteria:

* Minimum age 18yrs
* Patient resides at least 6 months in nursing home "het Gielsbos".
* Patient always gets a sedative protocol to make dental care delivery possible.
* Informed consent was obtained from parent/guardian
* No medical contra-indication for any of tested sedative protocols

Exclusion Criteria:

* Age under 18yrs
* The patient is no resident of the nursing home "het Gielsbos" or lives there for less than 6 months.
* No need for medicinal support during dental treatment
* No informed consent was obtained by parents or the guardian of the patient.
* Medical contra-indication for 1 of the sedative protocols

Primary outcomes:
measure: Level of cooperation of patient when receiving regular dental care
timeFrame: Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes.
Secondary outcomes:
measure: Recording of vital parameters during regular dental care delivery
timeFrame: 24 hrs
measure: Level of patient comfort and possible side-effects after dental treatment session
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
Study officials:
affiliation: KU Leuven
name: Dominique Declerck
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01369836: Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects
Official title: An Investigator And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06291826 (Tafamidis) After Single Oral Administration To Japanese And Western Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Tafamidis
Pharmacokinetics
TTR stabilization
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is the following:

* To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose.
* To compare Japanese and Western PK profiles.
* Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.


Eligibility criteria: Inclusion Criteria:

* Healthy male or females.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

Exclusion Criteria:

* Pregnant or nursing females.
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.

Primary outcomes:
measure: Plasma concentration of tafamidis over time (AUClast).
timeFrame: 2 months
measure: Plasma concentration of tafamidis over time (Cmax).
timeFrame: 2 months
measure: Plasma concentration of tafamidis over time (Tmax).
timeFrame: 2 months
measure: If data permit, AUCinf and t1/2 will be determined.
timeFrame: 2 months
Secondary outcomes:
measure: The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers.
timeFrame: 2 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00840736: LAGB Versus VBG: 7-Year Results
Official title: Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Bariatric Surgery
Vertical Banded Gastroplasty
Laparoscopic Adjustable Gastric Banding
Long Term Results
Keywords: VBG
LAGB
long term results
Weight loss
Complications
Reoperations
Conversion
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the long term results of a randomized clinical single-centre trial comparing two standard operative techniques in bariatric surgery; laparoscopic adjustable gastric banding and vertical banded gastroplasty.

Detailed description: One hundred morbidly obese patients were included in the study. Randomization between the two operative techniques was performed using a computer model. Fifty patients were included in both groups. Weight loss, obesity-related comorbidity, long term complications, re-operations and conversions were all prospectively investigated for a mean period of 84 months.

Eligibility criteria: Inclusion Criteria:

* BMI of \> 40 kg/m2 or \> 35 kg/m2 with obesity-related comorbidities
* Failure to achieve sustainable weight loss with proven conservative measures

Exclusion Criteria:

* severe psychiatric and / or eating disorders
* unable to keep to a prescribed postoperative diet
* \< 18 or \> 60 years
* not eligible to bariatric surgery according to a member of the multidisciplinary team (psychologist, dietician, nurse practitioner, general practitioner and surgeon)

Primary outcomes:
measure: weight loss
timeFrame: 84 months
Secondary outcomes:
measure: co-morbidity
timeFrame: 84 months
measure: complications
timeFrame: 84 months
measure: reoperations / revisions / conversions
timeFrame: 84 months
measure: Quality of life
timeFrame: 84 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Atrium Medical Centre Parkstad
name: Jan Willem M Greve, Md PhD
role: STUDY_DIRECTOR
affiliation: Atrium Medical Centre Parkstad
name: Ruben Schouten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04353336: Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment
Official title: Clinical Study Evaluating the Efficacy of Chloroquine or Hydroxychloroquine in COVID-19 Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Coronavirus Infection
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 194
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chloroquine or hydroxychloroquine in COVID-19 treatment

Detailed description: Clinical Study Evaluating the Efficacy of Chloroquine or hydroxychloroquine in COVID-19 treatment

Eligibility criteria: Inclusion Criteria:

* Covid 19 patients

Exclusion Criteria:

* Allergy or contraindication to the drug
* Pregnant or lactating
* Patients with cardiac problems

Primary outcomes:
measure: Number of patients with cure or death
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University, Assiut University
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01974336: The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients
Official title: The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Parenteral Nutrition-associated Cholestasis in Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Short Bowel Syndrome
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in adults with short bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients with short bowel syndrome supported by total parenteral nutrition.
* Patients have intestine more than 50cm.
* Requirements of informed consent and assent of participant, parent or legal guardian as applicable
* Consciousness and ability to cooperate.

Exclusion Criteria:

* Patients have obstruction of biliary tract, infection, autoimmune disease, cancer
* Patients have intestine less than 50cm
* A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease
* Female with positive pregnancy
* Allergy to ursodeoxycholic acid

Primary outcomes:
measure: The biochemical indicator of patients' liver function during oral UDCA or placebo
timeFrame: 2 months
Secondary outcomes:
measure: the changs of composition of serum bile acid after oral UDCA or placebo
timeFrame: 2 months
measure: The changs of the level of fibroblast growth factor 19(FGF19) in the serum
timeFrame: 4 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing University
name: Wencheng Kong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00510536: Treatment of Mild to Moderate Joint Pain in Patients With Chronic Plaque Psoriasis Receiving Efalizumab
Official title: A Phase 4 Study to Assess the Practical Management of Mild to Moderate Arthritic or Arthralgic Events in Patients With Chronic Plaque Psoriasis Receiving Efalizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis
Arthralgia
Keywords: Psoriasis, arthritis, arthralgia
Lead sponsor: Probity Medical Research
Sponsor class: NETWORK
First posted: 2007-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate tolerability and effectiveness of conventional treatment for mild to moderate arthritic or arthralgic symptoms while subjects are being treated with efalizumab for psoriasis.

Detailed description: The study objective is to demonstrate that mild to moderate arthritis or arthralgia may be controlled using conventional therapy while being treated with efalizumab, without loss of efficacy.

Eligibility criteria: Inclusion Criteria:

* Females cannot become pregnant while participating in study.
* Have a history of plaque psoriasis for at least 6 months.
* Receiving or about to receive efalizumab for the treatment of chronic plaque psoriasis.
* Have mild to moderate arthritis or arthralgia occurring while on treatment with efalizumab or untreated mild to moderate arthritis or arthralgia present at the time of initiating treatment with efalizumab.

Exclusion Criteria:

* Previous systemic treatment with biologics other than efalizumab, within 3 months.
* Treatment with any systemic corticosteroids or intra-articular corticosteroid injection, cyclosporine or methotrexate within 28 days.
* Any previous treatment with chlorambucil or cyclophosphamide.
* Have active tuberculosis or are currently receiving treatment or prophylactic therapy for tuberculosis.
* Have other serious disorders; such as, congestive heart failure, prior or current history of blood dyscrasia, or central nervous system demyelinating disorders.
* Has a sensitivity, intolerance, or history of gastrointestinal bleeding associated with diclofenac, indomethacin, and/or ibuprofen.

Primary outcomes:
Secondary outcomes:
measure: The proportion of subjects who sustain or improve their psoriasis in response to efalizumab.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
Study officials:
affiliation: K. Papp Clinical Research Inc.
name: Kim Papp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03778736: Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes
Official title: Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
name: Quena IVF Center
First posted: 2018-12-19
Enrollment: 586
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived hyaluronidase followed by mechanical denudation through pipetting. A human recombinant hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns associated with the animal origin and lack of purity of the bovine-derived form of the enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs or lower remains an open question.


Eligibility criteria: Inclusion Criteria:

* ICSI indicated partcipants

Exclusion Criteria:

* severe medical disease

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 16 weeks
Secondary outcomes:
measure: Biochemical pregnancy
timeFrame: Two weeks
measure: Clinical pregnancy rate
timeFrame: 7 weeks
measure: Embryo developmental rate
timeFrame: 6 days of culture
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References: