louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05255055: Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain
Official title: Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 40
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: It has been estimated that between 50% and 85% of the population will suffer neck pain along their life. Chronic nonspecific neck pain is one of the main causes of disability in the population, it represents 25% of visits to physiotherapy, and it also has a high chance of chronification. The efficacy of combining manual therapy and therapeutic exercise for the treatment of this pathology has been demonstrated a lot of times. However, no conclusive studies have been found that compare the isolated application of both treatments, thus being an important focus of action and research.

The main objective of the study is to check if the treatment with therapeutic exercise is better than manual therapy in the improvement of the disability in patients with chronic neck pain.

A randomized, controlled, monocentric, parallel and single-blind clinical trial will be carried out.

The simple will be obtained from the population over 18 years old with chronic neck pain of more than 12 weeks of evolution and will be those who meet the inclusion and exclusion criteria.

The patients will be randomly divided into 2 intervention groups, in one of the groups will be applied a manual therapy session of about 30 minutes once a week for 4 weeks. In the other group it will be delivered and explained to the patients, a home therapeutic exercise program that will be carried out on alternate days for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Nonspecific cervical pain of more than 12 weeks of evolution.
* Over 18 years.

Exclusion Criteria:

* Oncological processes.
* Pregnancy.
* Infectious diseases.
* Degenerative diseases.
* Fibromyalgia.
* Previous spinal surgeries.
* Previous traumatic events.
* Hernias and/or cervical protrusions.
* Neurological processes.
* Current treatment for cervical pain.
* Neuropathic characteristics pain.

Primary outcomes:
measure: Neck Disability Index
timeFrame: Three months
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Three months
measure: Pressure Pain Threshold
timeFrame: Three months
measure: Life Quality SF-12
timeFrame: Three months
measure: Kinesiophobia TAMPA Scale
timeFrame: Three months
measure: Beck Depression Inventory II
timeFrame: Three months
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: University of Alcala
state: Madrid
Study officials:
References:
Clinical trial NCT01999855: Frequency of Dysphonia in Asthmatic Patients
Official title: Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthmatic Patients and Control Group
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: For many years, it is known that asthmatics have more often dysphonia. However, no study has so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.

The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time, inhaled corticosteroids have been considered as responsible for organic abnormalities of the vocal cords. We hypothesized that women with asthma have more often dysphonia, and that dysphonia is rather functional origin.


Eligibility criteria: Inclusion Criteria:

* Women
* Aged between 18 to 65 years
* Patient who signed the informed consent.
* affiliated with a social security system.

Patients with asthma (GINA criteria)

- persistent asthma with inhaled corticosteroids.

Primary outcomes:
measure: Evidence of dysphonia. The patient will be considered as having a dysphonia if at least one of the tests (Voice Handicap Index, Rank Rough Breathy Asthenic Strained GRBAS, Quotien Phonatoire QP and Fundamental laryngeal F0) is abnormal
timeFrame: Four week
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de pneumologie, d'allergologie et de pathologie de l'environnement
Study officials:
affiliation: Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg
name: Frédéric De Blay, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02150655: Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women
Official title: Pilot Study Investigating Bacteria (Microbiota), Their By-products (Metabolome) and Environmental Toxins in Relation to Reproductive Health in Rwandan Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vulvovaginal Candidiasis
Bacterial Vaginosis
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 30
Sex: FEMALE
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 overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 18 and 55.

Exclusion Criteria:

* \*Current infection of gonorrhoea, \*Chlamydia, genital warts, \*active genital herpes lesions, \*active syphilis; \*urinary tract infection including pyelonephritis (an ascending urinary tract infection); \*receiving drug therapy that may affect the vaginal flora; \*had unprotected sexual intercourse (vaginal or oral) within the past 48 hours; \*have used a vaginal douche, genital deodorant, or genital wipe products in the past 48 hours; \*have taken any 'acidophilus' 'bifidobacteria' or probiotic health food supplements in the past 48 hours; \*are menstruating at time of clinical visit.

Primary outcomes:
measure: maintenance of healthy vaginal microbiota
timeFrame: 1 month
Secondary outcomes:
measure: Reduction of environmental toxins in blood by lactobacilli
timeFrame: 1 month
Other outcomes:
Locations:
city: Nyamata
country: Rwanda
facility: Nyamata District Hospital
state: East Province
Study officials:
affiliation: Western University, Canada
name: Gregor Dr Reid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMillan A, Rulisa S, Gloor GB, Macklaim JM, Sumarah M, Reid G. Pilot assessment of probiotics for pregnant women in Rwanda. PLoS One. 2018 Jun 18;13(6):e0195081. doi: 10.1371/journal.pone.0195081. eCollection 2018.
Clinical trial NCT03115255: Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab
Official title: Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Keywords: retinopathy of prematurity
ranibizumab
vascular endothelial growth factor
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 17
Sex: ALL
Minimum age (years): 4
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab

Detailed description: Infants with ROP are studied. They received 0.25 mg or 0.5 mg of intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active ROP. Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab. The serum concentrations of ranibizumab and VEGF are measured by enzyme-linked immunosorbent assay, and the changes of the serum VEGF levels are determined.

Eligibility criteria: Inclusion Criteria:

* Infants with vascularly active ROP
* intravitreal ranibizumab

Exclusion Criteria:

* already accepted laser therapy

Primary outcomes:
measure: The effect of intravitreal ranibizumab on serum VEGF level
timeFrame: 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab
Secondary outcomes:
measure: The effect of intravitreal ranibizumab on weight
timeFrame: corrected age of six month
measure: The effect of intravitreal ranibizumab on height
timeFrame: corrected age of six month
measure: The effect of intravitreal ranibizumab on neurologic development
timeFrame: corrected age of six month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Hongping Xia, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351455: Watchful Waiting of Incisional Hernias
Official title: Watchful Waiting of Incisional Hernias: A Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Ventral Hernia
Umbilical Hernia
Keywords: hernia
incisional hernia
ventral hernia
umbilical hernia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2006-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be made between those who receive surgery and those who do not.

Detailed description: This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be made between those who receive surgery and those who do not.

Subjects will fill out three survey forms on quality of life and pain at baseline and again at six and 12 months. Measurements of change in hernia size will be made, life-style changes such as smoking cessation, weight-loss, tighter control of diabetes will be initiated for outcome comparison with controls.

Eligibility criteria: Inclusion Criteria:

1. abdominal hernia greater than 3 cm2
2. 18 years of age
3. able to give informed consent

Exclusion Criteria:

1. abdominal hernia less than 3 cm2 or greater than 127 cm2
2. unable to return to clinic for follow-up visits

Primary outcomes:
measure: Develop guidelines for hernia repair
Secondary outcomes:
measure: To measure if life-style changes lower need for hernia repair
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Charles Bellows, III, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01166555: Pharmacokinetics And Tolerability Of Subcutaneous Administration Of PF 04236921 In Healthy Volunteers
Official title: Phase I Pharmacokinetics And Tolerability Of PF-04236921 Following Subcutaneous Administration To Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety and tolerability
Pharmacokinetics
PF-04236921
Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.

Detailed description: Tolerability and Pharmacokinetics of subcutaneously administered dose of PF-04236921 in healthy volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy males between 18-55 years, inclusive.
* Healthy females of non-childbearing potential between 18 and 55 years, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Females of childbearing potential.

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: 5 months
measure: Incidence and severity of clinical findings on physical examination
timeFrame: 5 months
measure: Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements
timeFrame: 5 months
measure: Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate)
timeFrame: 5 months
measure: Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters
timeFrame: 5 months
Secondary outcomes:
measure: Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles
timeFrame: 5 months
measure: Incidence and level of ADA development
timeFrame: 5 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
Clinical trial NCT06909955: The Effect of Progressive Muscle Relaxation Exercises on Premenstrual Syndrome, Anxiety, and Tendency to Violence in Young Women
Official title: The Effect of Progressive Muscle Relaxation Exercises on Premenstrual Syndrome, Anxiety, and Tendency to Violence in Young Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premenstrual Disorder
Keywords: premenstrual syndrome
progressive relaxation exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study results will provide evidence on the effectiveness of Progressive Muscle Relaxation Exercises (PMRE) as a complementary method in improving Premenstrual Syndrome (PMS), an important women's health issue. Additionally, it will contribute to the literature by shedding light on irritability and anxiety, which are common side effects of PMS.


Eligibility criteria: Inclusion Criteria:

* Female students studying at Istanbul Aydın University, Faculty of Health Sciences, Those who score 111 or above on the Premenstrual Syndrome Scale (PMSS), Female students aged 18-24 will be included in the study.

Exclusion Criteria:

* Non-Turkish speakers, Individuals who cannot communicate normally, Students who are unable to comply with the exercise program will be excluded from the study.

Primary outcomes:
measure: Premenstrual Syndrome Scale
timeFrame: evaluations will be conducted at the day 1 and after 8 weeks.
measure: Violence Tendency Scale
timeFrame: evaluations will be conducted at the day 1 and after 8 weeks.
measure: Beck Anxiety Inventory
timeFrame: evaluations will be conducted at the day 1 and after 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01566955: Feasability Study of Removing the Ovaries and Fallopian Tubes
Official title: Feasability of Transgastric Adnexectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Diseases
Keywords: transgastric
NOTES
Gastrotomy
BRCA 1/2
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main reason for this trial is to show the feasibility of removing the ovarien and fallopian tubes through the gaster (transgastric adnexectomy). The background for it is to look for more indications of scarless surgery and we will show that the transgastric adnexectomy can be performed in an easy way. It is necessary that there is an indication for removing the ovaries and fallopian tubes and if the patient agree we will do it instead of through the belly through the gaster and maybe with an additional inzision in the vagina. All patients with indication for adnexectomy are potential candidates.

Detailed description: We will show the feasibility for transgastric adnexectomy in 10 patients. Patients for participating in the study suffer of benign adnexal deseases and there is an indication for removing them for diagnostic, prophylactic or therapeutic reasons. A flexible gastric scope is put transgastric into the abdomen, developing an pneumoperitoneum and removing the adnexes with a monopolar knife. The adnexes then are put out of the abdomen either transvaginally after colpotomy or even transgastric. We already performed an appendectomy in 24 patients and were able to show the feasibility in acute infectios situations.

Eligibility criteria: Inclusion Criteria:

* Indication for adnexectomy, agreement to take part in the study

Exclusion Criteria:

* No agreement in the trial; patients younger than 18 years of age

Primary outcomes:
measure: Number of Participants with conversion to laparoscopy or laparotomy
timeFrame: 12 months
Secondary outcomes:
measure: postoperative well being
timeFrame: 6 weeks and 6 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Center Mannheim
state: Baden-Württemberg
Study officials:
affiliation: University of Heidelberg, University Medical Center Mannheim Department of Obstetric and Gynaecology
name: Marc Suetterlin, MD; PhD
role: STUDY_CHAIR
References:
citation: Hornemann A, Suetterlin M, Trunk MJ, Gerhardt A, Kaehler G. Pure natural orifice transluminal endoscopic surgery (NOTES) involving peroral endoscopic salpingo-oophorectomy (POESY). Int J Gynaecol Obstet. 2014 Apr;125(1):86-8. doi: 10.1016/j.ijgo.2013.08.024. Epub 2014 Jan 2.
Clinical trial NCT06456255: Bupivacaine and Epinephrine Injection Study
Official title: Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Sinus Disease
Anesthesia
Bleeding
Keywords: endoscopic sinus surgery
bupivacaine
epinephrine
Lead sponsor: St. Paul's Hospital, Canada
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We propose a double-blind, parallel arm, randomized controlled trial evaluating whether injecting 0.25% bupivacaine with 1:200,000 epinephrine is superior to no injection (sham procedure) during ESS.
Primary purpose: TREATMENT

Brief summary: Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.


Eligibility criteria: Inclusion Criteria:

* Age 19 years or older
* Scheduled for primary ESS (including septoplasty)

Exclusion Criteria:

* Cystic fibrosis
* Systemic vasculitis or any bleeding disorders
* Known or suspected hypersensitivity to bupivacaine or epinephrine
* Previous sinus surgery
* Inhaled drug use (i.e., cocaine) in the preceding 6 months
* Nasal tumors
* Patients on antiarrhythmics.
* Patients with history of severe liver illness.
* Patients identified as high-risk for complications during preoperative assessment with the anesthesiologist (e.g. untreated hypertension, ischemic heart disease, cerebral vascular insufficiency, heart block, peripheral vascular disorder, uncontrolled hyperthyroidism and diabetes)

Primary outcomes:
measure: Boezzart bleeding score
timeFrame: throughout study completion, one day study visit
Secondary outcomes:
measure: Total blood loss
timeFrame: throughout study completion, one day study visit
measure: Surgical time
timeFrame: throughout study completion, one day study visit
measure: Mean arterial pressure (MAP)
timeFrame: throughout study completion, one day study visit
measure: Postoperative bleeding
timeFrame: throughout study completion, one day study visit
measure: Postoperative pain
timeFrame: throughout study completion, one day study visit
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St.Paul's Hospital Sinus Center
state: British Columbia
Study officials:
References: