louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03536013: Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy
Official title: A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound
Herniation
Lead sponsor: StimLabs
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blind study
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.

Detailed description: The primary objective is to evaluate the efficacy of full thickness placental allograft use in improving back and leg pain, when applied to patients undergoing lumbar microdiscectomy.

Eligibility criteria: Inclusion Criteria:

* Ambulatory with radiating low back and leg pain for greater than 6 months prior to surgery with clinical diagnosis of lumbar protruding disc.
* Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.

Exclusion Criteria:

* Severe hypertension systolic blood pressure (greater than or equal to 200 mm -Hg or diastolic blood pressure greater than or equal to 182 mm Hg)
* BMI greater than 45 kg/m2
* Subject has had major surgery at the index level
* Is an active smoker or stopped smoking in the last 6 months
* Any pain that could interfere with the assessment of index level pain (e.g. pain in any other part of the spine)
* Active rheumatoid arthritis
* Active, local or systemic malignancy such as lung cancer or leukemia
* History of vascular disease or sickle cell anemia
* Use of the following medications:

No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)

* No systemic treatments that may interfere with safety or efficacy assessments during the study
* No immunosuppressants
* No use of corticosteroids

  * Subject is pregnant or plans to become pregnant within 24 months of treatment
  * Subject does not provide full consent
  * Personal injury, workman's compensation or other legally-related treatment patients.

Primary outcomes:
measure: Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
timeFrame: 24 months
measure: Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
timeFrame: 24 months
Secondary outcomes:
measure: Evaluation of post-microdiscectomy reherniation rate.
timeFrame: 24 month
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Polaris Spine and Neurosurgery
state: Georgia
Study officials:
affiliation: Polaris Spine and Neurosurgery
name: Thomas Morrison, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911313: Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome
Official title: Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
clomiphene resistance
letrozole
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.

Detailed description: Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all patients in the combined metformin-CC group) received metformin HCl \[Cidophage®; Chemical Industries Development(CID), Cairo, Egypt\], 500 mg three times daily for 6-8 weeks. Then after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment for three successive cycles using the same protocol. Metformin was stopped only when pregnancy was documented.

Eligibility criteria: Inclusion Criteria:

* CC resistant PCOS

Exclusion Criteria:

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors

Primary outcomes:
measure: Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).
Secondary outcomes:
measure: The occurrence of pregnancy and miscarriage.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals,OB/GYN department
state: Dakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Hatem Abu Hashim, MD. MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University Hospital
name: Tarek Shokair, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University Hospital
name: Ahmed Badawy, MD.PhD.
role: STUDY_CHAIR
References:
citation: Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
citation: Siebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.
Clinical trial NCT03537313: Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy
Official title: Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy: A Factorial 2-by-2 Open-labeled Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Febrile Morbidity
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2018-05-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial 2-by-2 open labeled randomised controlled trial
Primary purpose: PREVENTION

Brief summary: Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy

Detailed description: Total abdominal hysterectomy (TAH) is the most common gynecologic operation worldwide. The two most common complications after TAH are febrile and infectious morbidities, incidence varying between 5 and 50 percent. After performing TAH, vaginal canal must be breached and closed to be blind-pouch stump. Routing vaginal douching at the night before and on the morning of the surgical date, and intra-operative painting are routinely practiced. However, no good quality of evidence base supports the effectiveness of vaginal douching and painting in preventing febrile and infectious morbidities after TAH.

Eligibility criteria: Inclusion Criteria:

* Women who undergoing total abdominal hysterectomy
* Woman who agrees to participate in this study

Exclusion Criteria:

* Women with history of sea-food or iodine allergy
* Women who undergo emergency TAH
* Women who have intestinal resection in this operation
* Women who have active pelvic inflammatory disease before operation
* Women who have fever before operation
* Women who received antibiotic within 1 weeks before operation
* Women who be immunocompromised host

Primary outcomes:
measure: Febrile morbidity
timeFrame: Day 1-7 after surgery
Secondary outcomes:
measure: Vaginal cuff infection
timeFrame: 2 weeks after surgery
measure: Other infectious morbidities
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi hospital
Study officials:
References:
Clinical trial NCT05838313: Should I Have an Elective Induction?
Official title: Should I Have an Elective Induction? The SELECTION Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Induced
Patient Preference
Keywords: Shared Decision Making
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: University of California, San Francisco
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-05-01
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of the proposed study is to perform a pilot test of a patient-centered decision support tool to help pregnant people and providers work together in making informed, shared decisions regarding whether or not to opt for elective IOL at 39 weeks gestation

Detailed description: 60 nulliparous pregnant people with singleton, vertex pregnancies at 36-38 weeks who do not have an indication for induction of labor (IOL) will be enrolled and will view a decision support tool (DST) regarding induction without medical indication. During the enrollment face-to-face interview, participants will interact with the DST and complete pre- and post-DST viewing questionnaires. The investigators will conduct telephone interviews a few days later but before 39+0 weeks, and again 2-4 weeks postpartum and will review the medical record for delivery events and outcomes.

Eligibility criteria: Inclusion Criteria:

* Pregnant person
* Nulliparous
* Planned vaginal delivery
* No medical indication for induction of labor

Exclusion Criteria:

* Contraindication to vaginal delivery
* Prior delivery (vaginal or cesarean)
* Medical indication for induction of labor

Primary outcomes:
measure: Recruitment Rate
timeFrame: 32-38 weeks gestation
measure: Proportion of People Completely Viewing the Decision Support Tool
timeFrame: 36-38 weeks gestation
Secondary outcomes:
measure: Satisfaction With the Decision Support Tool
timeFrame: 36-38 weeks gestation
measure: Satisfaction With the Decision Support Tool
timeFrame: 38-39 weeks gestation, prior to delivery
measure: Impact of App on Decision Making
timeFrame: 2-4 weeks Postpartum
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT02016313: The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus
Official title: Evaluation of the Effect of Cervical Spine Treatment in Tinnitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2013-12-19
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 purpose of this study is to determine whether physiotherapy is effective in the treatment of a group of tinnitus patients with neck complaints.


Eligibility criteria: Inclusion Criteria:

* severe chronic non-fluctuating subjective cervicogenic somatic tinnitus, which has been stable for at least three months, combined with neck complaints

Exclusion Criteria:

* objective tinnitus
* subjective tinnitus with etiologies, such as hearing loss or Meniere's disease, severe depression (\> 19 on the Beck depression questionnaire)
* progressive middle ear pathology
* intracranial pathology
* traumatic cervical spine injury
* tumors
* cervical spine surgery
* any cervical spine condition in which physical therapy treatment is contra- indicated
* received physical therapy treatment directed to the cervical spine in the past 2 months

Primary outcomes:
measure: Change in Tinnitus Functional Index
timeFrame: pre treatment, post treatment, 6 and 12 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital of Antwerp
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Paul Van de Heyning, PhD, MD
role: STUDY_CHAIR
affiliation: Universiteit Antwerpen
name: Willem De Hertogh, PhD
role: STUDY_CHAIR
References:
citation: Michiels S, Van de Heyning P, Truijen S, Hallemans A, De Hertogh W. Does multi-modal cervical physical therapy improve tinnitus in patients with cervicogenic somatic tinnitus? Man Ther. 2016 Dec;26:125-131. doi: 10.1016/j.math.2016.08.005. Epub 2016 Aug 26.
citation: Michiels S, De Hertogh W, Truijen S, Van de Heyning P. Physical therapy treatment in patients suffering from cervicogenic somatic tinnitus: study protocol for a randomized controlled trial. Trials. 2014 Jul 22;15:297. doi: 10.1186/1745-6215-15-297.
Clinical trial NCT00092313: A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)
Official title: A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: dental surgery
molar removal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 271
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Detailed description: The duration of treatment is 24 hours.

Eligibility criteria: Inclusion Criteria:

* Impaction of a molar tooth requiring removal

Exclusion Criteria:

* Known allergy to the study drugs

Primary outcomes:
measure: Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.
Secondary outcomes:
measure: Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chang DJ, Desjardins PJ, Bird SR, Black P, Chen E, Petruschke RA, Geba GP. Comparison of rofecoxib and a multidose oxycodone/ acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial. Curr Med Res Opin. 2004 Jun;20(6):939-49. doi: 10.1185/030079904125003863.
Clinical trial NCT01756313: Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Photodynamic Therapy
Ablative Fractional Laser
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2012-12-25
Enrollment: 12
Sex: MALE
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 objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin:

1. Increases the uptake of Methylaminolevulinat (MAL) in the skin.
2. Decreases the required incubation time of MAL when performing photo dynamic therapy.

Detailed description: 12 healthy male individuals were included.

On the back, 25 areas measuring 2.8x2.8 cm were marked, plus one control area. We tested 2 variables.

1) Density of laser channels. 2) Methylaminolevulinat (MAL) concentration

1. Laser - Each area was randomized to receiving:

   * no treatment
   * 1% laser channel density
   * 2% laser channel density
   * 5% laser channel density
   * 10% laser channel density
   * 15% laser channel density
2. MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive:

   * vehicle
   * 4% MAL
   * 8%MAL
   * 16%MAL

The uptake of MAL was evaluated by fluorescence intensity measured with a florescence camera at t=

* 0min
* 30min
* 1h
* 1.5h 2h 2.5h 3h

Eligibility criteria: Inclusion Criteria:

* Male
* \>18 years old
* Fitzpatrick skin type I-III
* No UV exposure thee months prior to study
* Signed study consent

Exclusion Criteria:

* Known allergy to substances in MAL or Unguentum M cream.
* Previous keloid
* Use of topical or systemic photosensitizing drug
* Evaluated to not be able to follow treatment protocol

Primary outcomes:
measure: Fluorescence Intensity
timeFrame: up to 3 hours
Secondary outcomes:
Other outcomes:
measure: Skin reactions
timeFrame: 24h
Locations:
city: Copenhagen
country: Denmark
facility: Department of Dermatology, Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483313: Intelligence Changes Following Minor Surgery
Official title: Intelligence Performance in Adolescence After Early Exposure to Anesthesia and Minor Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypospadia
Phimosis
Inguinal Hernia
Keywords: Anesthestics
Minor surgery
Wechsler Intelligence Scale for Children
Cognitiion
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Medical Center
First posted: 2011-12-01
Enrollment: 0
Sex: MALE
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators would like chose the Children who undergone minor surgery in Renji hospital 4-6years ago and their friends who never had any surgery.

Brief summary: Animal studies showed that many general anesthetics might result in neuron apoptosis and neurocognitive impairment in the developing brain. However results from human studies are conflicted. In present study, the investigators examined the association between early exposure to anesthesia and surgery for minor surgery and intelligence changes in adolescence using the Wechsler Intelligence Scale for Children.


Eligibility criteria: Inclusion Criteria:

1. Born from 1995
2. Male
3. Parents or guardian agree to attend this study
4. Undergone minor surgery (Repair of hypospadias, phimosiectomy, cryptorchidectomy or cryptorchidopexy and repair of inguinal hernia)
5. Children who scarify the No.1 to No.3 but no experience of any surgery.
6. Those who undergone minor surgery in Renji Hospital 4-6years ago.

Exclusion Criteria:

1. Any congenital central nervous system diseases
2. Any congenital heart diseases
3. Any congenital dysgnosia
4. Birth weight less than 2kg
5. Ever been hypoxic encephalopathy when birth

Primary outcomes:
measure: Wechsler Intelligence Scale for Children
timeFrame: Average 5 years after surgery
Secondary outcomes:
measure: Achenbach Child Behavior Checklist
timeFrame: Average 5 years after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital
name: Diansan Su, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00036413: A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: (ALS)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-05-10
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is the first to be performed in Amyotrophic Lateral Sclerosis (ALS) patients with the novel compound TCH346. Its purpose is to evaluate the safety and clinical effects of 3 dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of laboratory-supported probable, probable or definite ALS. The study will require patients to visit the study center a total of at least 7 times over the course of up to 14 weeks. The study consists of 2 phases: A screening phase (up to 2 weeks) when patients will be evaluated for eligibility to participate in the study, and a double-blind treatment phase (12 weeks) when patients will receive daily doses of either TCH346 or placebo and will be evaluated for clinical effects. In addition, patients eligible to participate in this study will be required to have 3 magnetic resonance spectroscopic (MRS) scans. The MRS is a non-invasive, painless, "brain scan". The MRS will require traveling to a designated center in Montreal, Canada, which is very experienced in performing such MRS scans in ALS patients.


Eligibility criteria: * clinical diagnosis of laboratory-supported probable, probable, or definite ALS;
* have sporadic or familial ALS;
* have shown ALS symptom onset for no more than 3 yrs., inclusive, prior to randomization;
* FVC of \>60%;
* ability to tolerate MRS evaluation

Primary outcomes:
measure: Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS
Secondary outcomes:
measure: Biomarker assessments at week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Neurological Institute
state: New York
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: