louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00388856: Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
Official title: Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preeclampsia
Keywords: antioxidant supplementation
preeclampsia
prevention
Lead sponsor: Showa University
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2006-10-17
Enrollment: 400
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate antioxidants supplementation in pregnant women with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy outcome in randomized prospective study.

Detailed description: Preeclampsia still remains a leading cause of feto-maternal mortality and morbidity in developed and developing world. Despite of intensive research, the underlying pathologic mechanisms of this disease remain elusive. It has been agreed that incomplete or absent transformation of spiral arteries by replacing endothelial cells and mural vascular smooth muscle cells has been observed in the placental bed of preeclamptic patients and severe cases of intrauterine growth restriction. Oxidative stress has been proposed as a link between these mechanisms. However, it has been demonstrated by two large studies that antioxidant supplementation does not reduce the risk of preeclampsia. Our initial study has been shown that antioxidant supplementation may be reduce the risk of preeclampsia in pregnant women with low antioxidant status.

Comparison(s): adverse pregnancy outcome between vitamin C and E given and placebo given to pregnant women with low antioxidant status at 10-12 weeks gestation age

Eligibility criteria: Inclusion Criteria:

* Agree to consent form, and consent to protocol of research
* Known healthy singleton 6-10 weeks pregnant women

Exclusion Criteria:

* Blood pressure \> 135/85
* Proteinuria
* History or current use of anti-hypertensive medication or diuretics
* Use of vitamins C \> 150 mg and/or E \> 75 IU per day
* Pregestational diabetes
* Known placental abnormalities.
* Current pregnancy is a result of in vitro fertilization
* Regular use of platelet active drugs or non-steroidal anti-inflammatory drugs
* Known fetal abnormalities
* Documented uterine bleeding within a week of screening
* Uterine malformations
* History of medical complications
* Illicit drug or alcohol abuse during current pregnancy
* Intent to deliver elsewhere
* Known psychologic problems.
* Participating in another interventional study

Primary outcomes:
measure: preeclampsia cases
Secondary outcomes:
measure: adverse pregnancy outcome
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National Hospital
Study officials:
affiliation: Showa University School of Medicine
name: Akihiko Sekizawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06472856: Vasomotor Symptom Alleviation Through Acupuncture in Patients With Prostate Cancer
Official title: Vasomotor Symptom Alleviation Through Acupuncture in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Bon Secours Hospital, Cork
First posted: 2024-06-25
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot study to assess the acceptability and efficacy of acupuncture in alleviating vasomotor symptoms (hot flushes and night sweats) in Irish patients with prostate cancer receiving androgen deprivation therapy.


Eligibility criteria: Inclusion Criteria:

* All participants must have a histologically confirmed diagnosis of prostate cancer and currently be treated with androgen deprivation therapy with or without additional prostate cancer therapies.
* Patients under the care of a Medical Oncologist in either Bons Secours Hospital or Cork University Hospital
* All participants must be experiencing moderate to severe vasomotor symptoms as defined by a score of 4 or more on the Hot Flash Index.

Exclusion Criteria:

* Patients under 18.
* Patients with HFI scores below 4.
* Patients not currently being treated with androgen deprivation therapy.
* Patients with contraindications to acupuncture.
* Patients already receiving acupuncture for vasomotor symptoms.
* Patients unwilling to participate in the study.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Secondary outcomes:
measure: Changes in symptom interference scores
timeFrame: Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
measure: Changes in sleep quality
timeFrame: Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Bons Secours Hospital
Study officials:
References:
Clinical trial NCT02059356: Ammonia Levels and Cognitive Impairment
Official title: Prevalence of High Ammonia Levels in Patients With Cognitive Impairment. Does Treatment Help?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dementia
Cognitive Decline
Cognitive Impairment
Developmental Delay
Keywords: Dementia
Alzheimer's
Alzheimers
Cognitive decline
Cognitive impairment
Memory loss
Memory disorder
Forgetfulness
Confusion
Senile
Demented
Developmental delay
Portal systemic shunting
High ammonia level
Elevated ammonia level
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of assisted living center or the general public

Brief summary: The purpose and objective of this study is to determine the prevalence of elevated ammonia levels in subjects with cognitive impairment, and to observe if treating the cause of the elevated ammonia level improves mental status. This study does not include any imaging, treatment,or interventions, other than the blood draws. The blood draws will be taken to assess blood ammonia level and liver function. If the the ammonia level is not elevated, no further lab draws will occur. If the ammonia level is elevated, liver function is normal, and a cause for the high ammonia level is revealed with a plan for clinical treatment by the subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3 months after treatment. The main risk to subjects is related to the blood draw (i.e. momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a potential loss of confidentiality. A paired student t test will be done with the two later blood to compare objective data.


Eligibility criteria: Inclusion Criteria:

* cognitive decline (suspected or documented)
* able to get blood drawn

Exclusion Criteria:

* liver disease/cirrhosis

Primary outcomes:
measure: Change in blood ammonia level
timeFrame: Baseline, Pretreatment and 3 months after treatment
Secondary outcomes:
measure: Change in mini-status examination
timeFrame: Prior to treatment and 3 months after treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
References:
Clinical trial NCT00464256: Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation
Official title: Comparison of the Efficacy and Safety of a 20 mg/Day Oral Dose of Rimonabant Versus Placebo as an Aid to Smoking Cessation - a US, Randomized, Double-blind, 2 Arm, Placebo-controlled, Parallel-group, Fixed Dose, 12-week Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: abstinence
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-23
Enrollment: 533
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: The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker.

The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period.


Eligibility criteria: Inclusion Criteria:

* Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* Non tobacco cigarettes consumption
* Chronic use of marijuana
* Pregnancy, breastfeeding
* Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

Primary outcomes:
measure: Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
Secondary outcomes:
measure: Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
measure: Safety data
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01800656: Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy
Official title: Endoloop-assisted Colorectal Polypectomy or "Ligate and Let go" in Patients With Long-term Antiplatelet Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyp
Lead sponsor: Hospital Danilo I Cetinje
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2) safety and feasibility of endoloop assisted snare polypectomy in patients with long-term antiplatelet therapy; 3) safety and feasibility of so called "ligate and let go" approach in patients with long-term antiplatelet therapy.


Eligibility criteria: Inclusion Criteria:

* pedunculated colorectal polyps
* larger than 2cm in diameter
* long-term antiplatelet therapy

Exclusion Criteria:

* presence of intraepithelial

Primary outcomes:
measure: Post-polypectomy bleeding
timeFrame: 24h-15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Danilo I Cetinje
name: Milutin Bulajic, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05553756: Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section
Official title: Impact of Maltodextrin, Given 2 Hours Before Cesarean Section, on Glycemic and Hemodynamic Management of Pregnant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: University of Foggia
Sponsor class: OTHER
Collaborators: name: Casa Sollievo della Sofferenza IRCCS
First posted: 2022-09-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal is to evaluate the glycemic and hemodynamic stability in patients undergoing caesarean section in patients treated with maltodextrins two hours before the cesarean section

Detailed description: The patients undergoing elective cesarean section will be randomly divided in two groups: patients who drink 200 ml of clear liquid two hours before surgery or patients treated with 200 ml maltodextrins two hours before the surgery. The glycemic control will be done immediately before the maldodextrin administration and after the cesarean section by gluco stick. Standard hemodynamic monitoring ECG, Heart Rate, Blood pressure, Temperature, preipheral oxygen saturation will be done routinely.

Eligibility criteria: Inclusion Criteria:

* informed consent
* first cesarean section
* single fetus
* ASA I-II

Exclusion Criteria:

* BMI\<18
* BMI\>35
* contraindication to spinal anesthesia
* cardiovascular diseases

Primary outcomes:
measure: Glycemic stability
timeFrame: perioperative
measure: hemodynamic stability
timeFrame: perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: University of Foggia
Study officials:
References:
Clinical trial NCT04278456: Postpartum Depression
Official title: The Effect of the Anesthesia Modality Used in Women Giving Birth Under Caesarian Section on Postpartum Depression and/or Postoperative Melatonin Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Depression
Melatonin
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women that will give birth by c-section (using general or regional anesthesia) aged between 18-45 years will be included to our study

Brief summary: Our aim was to diagnose and initiate early treatment for postpartum depression by detecting the changes of melatonin levels in c-sections with different antesthesia modalities.


Eligibility criteria: Inclusion Criteria:

* pregnant women c-section (using general or regional anesthesia) aged between 18-45 years

Exclusion Criteria:

* age under 18 or above 45, history of smoking, a diagnosis with mental retardation, psychiatric patients, use of antipsychotics or antidepressants, patients with sleeping disorders, hormone replacement theraphy patients.

Primary outcomes:
measure: edinburgh depression scale
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan Byu
Study officials:
affiliation: ERZİNCAN
name: Remziye Ayşenur NALBANT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen LP, Werner MU, Rosenberg J, Gogenur I. A systematic review of peri-operative melatonin. Anaesthesia. 2014 Oct;69(10):1163-71. doi: 10.1111/anae.12717. Epub 2014 May 19.
citation: Maitra S, Baidya DK, Khanna P. Melatonin in perioperative medicine: Current perspective. Saudi J Anaesth. 2013 Jul;7(3):315-21. doi: 10.4103/1658-354X.115316.
citation: Dianatkhah M, Ghaeli P, Hajhossein Talasaz A, Karimi A, Salehiomran A, Bina P, Jalali A, Ghaffary S, Shahmansouri N, Vejdani S. Evaluating the Potential Effect of Melatonin on the post-Cardiac Surgery Sleep Disorder. J Tehran Heart Cent. 2015 Jul 3;10(3):122-8.
Clinical trial NCT03577756: Neurodevelopmental Assessment of Infants With Cystic Fibrosis
Official title: Neurodevelopmental Assessment Outcomes of Infants With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Disorders
Cystic Fibrosis
Keywords: cystic fibrosis
neurodevelopment
early rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 24
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants with cystic fibrosis will be provided from the Hacettepe University Faculty of Medicine, Pediatric Chest Diseases Clinic and healthy infants will be provided from the Hacettepe University Department of Physiotherapy and Rehabilitation Developmental and Early Physiotherapy Unit.

Brief summary: Infants included in the study will be divided into two groups as healthy infants and cystic fibrosis infants . Demographic, natal and postnatal information of the infants will be available from patient files. 12 months infants with cystic fibrosis and healthy infants will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Gross Motor Function Measure. The assessment outcomes of healthy and cystic fibrosis infants will be compared.


Eligibility criteria: Inclusion Criteria:

* having diagnosis of cystic fibrosis
* to be postterm24-36 months old

Exclusion Criteria:

* Having congenital anomalies,
* Having an acute infection,
* Risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (IVH / PVL), bronchopulmonary dysplasia,
* The baby's family not reluctant to involved in study.

Primary outcomes:
measure: Gross motor function measure (GMFM) score
timeFrame: about 30 minutes
measure: The Bayley Scales of Infant Development, Third Edition (BSID III)
timeFrame: about 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
citation: Sitrin MD, Lieberman F, Jensen WE, Noronha A, Milburn C, Addington W. Vitamin E deficiency and neurologic disease in adults with cystic fibrosis. Ann Intern Med. 1987 Jul;107(1):51-4. doi: 10.7326/0003-4819-107-1-51.
citation: de Almeida Thomazinho P, de Miranda Chaves CR, Passaro CP, Meio MD. Motor delay in cystic fibrosis infants: an observational study. Early Hum Dev. 2011 Dec;87(12):769-73. doi: 10.1016/j.earlhumdev.2011.05.012. Epub 2011 Jun 15.
citation: Singer L, Yamashita T, Lilien L, Collin M, Baley J. A longitudinal study of developmental outcome of infants with bronchopulmonary dysplasia and very low birth weight. Pediatrics. 1997 Dec;100(6):987-93. doi: 10.1542/peds.100.6.987.
citation: Tekerlek H, Yardimci-Lokmanoglu BN, Inal-Ince D, Ozcelik U, Mutlu A. Developmental Functioning Outcomes in Infants With Cystic Fibrosis: A 24- to 36-Month Follow-Up Study. Phys Ther. 2022 Jun 3;102(6):pzac037. doi: 10.1093/ptj/pzac037.
Clinical trial NCT06894056: Investigating the Effects of Orienting Skin Grafts Parallel to Skin Tension Lines on Quality of Life in Head and Neck Located Basal Cell Carcinoma
Official title: "Cerrahi Eksizyon ve Greft Ile Tedavi Edilmiş Olan Nonmelanoma Deri Kanseri Hastalarda Greft Donör Alanı Ile Post Operatif 3. Ayda Yaşam Kalitesinin İlişkisinin Araştırılması"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Cancer
Grafting
Keywords: basal cell carcinoma
skin tension lines
grafting
cosmetic outcome
quality of life
Lead sponsor: Sifa Okulu - Independent Research Center of Dermatology and Venereology
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were selected from the individuals who were admitted or referred to study center (Dr. Hilayda Karakok Private Practice of Dermatology and Venereology).

Brief summary: The goal of this observational study is to learn about the effect of orienting graft for treatment of skin cancer in patients who undergo skin cancer excision and grafting for their skin cancer. The main question to answer is

Does orienting the grafts parallel with skin tension lines have any effect on quality of life or cosmetic results?

Participants who already underwent or planned to undergo an excision and grafting procedure will answer a qaulity of life tool and cosmetic results will be evaluated by two seperate dermatologist.


Eligibility criteria: Inclusion Criteria:

* Patients with nodular basal cell carcinomas with a tumor size equal or less than 12 millimeters
* A history of surgical excision and grafting

Exclusion Criteria:

* Immunosuppressed patients
* Recurrent tumors
* Patients with BCC's that arose from the previously irradiated area
* Gorlin's Syndrome diagnosis
* Illiterate individuals
* İmpaired cognitive functions

Primary outcomes:
measure: Quality of Life Outcome
timeFrame: At least three months after surgery and grafting
measure: Quality of Life - General
timeFrame: At least three months after surgery and grafting
Secondary outcomes:
measure: Cosmetic Outcome
timeFrame: At least three months after the surgery and grafting
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Dr. Hilayda Karakök Deri ve Zührevi Hastalıklar Muayenehanesi
Study officials:
affiliation: Dr. Hilayda Karakök Muayenehanesi
name: Hilayda Karakök Kışla, MD, Specialist of Dermatology
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05414656: A Clinical Trial of Composite Class II Restorations With Two Different Matrix Bands
Official title: Comparison of Saddle Contoured Metal Matrix and Pre-contoured Self-adhesive Matrix in Composite Resin Class II Restorations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Caries in Posterior Teeth
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2022-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Various procedures and techniques have been devised in an attempt to generate tighter and more anatomic proximal contacts with class II composite restorations. The investigators study focuses on using Saddle contoured metal matrix and pre-contoured self-adhesive matrix .Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables.

Detailed description: A total of 60 posterior teeth with proximal cavity to be assigned on alternate basis in two equal groups. Group A teeth received the Saddle contoured metal matrix and group B pre-contoured self-adhesive matrix after cavity preparation.

All teeth to be restored with Nano hybrid composite restorative material. Outcome of proximal contours and contact tightness is determined by a blinded assessor just after the restoration.

Eligibility criteria: Inclusion Criteria:

* • Permanent fully erupted teeth with class II supra-gingival caries or the necessity of replacing class II restoration.

  * The patient who has adjacent teeth available for the contact with surrounding tooth structure.
  * Teeth with cavity isthmus less than one-third of inter-cuspal distance

Exclusion Criteria:

* • Partially erupted or deciduous teeth.

  * Teeth with orthodontic bands or brackets.
  * 3rd Molar and rotated teeth.
  * Teeth with dental caries extending up to pulp with periapical pathosis or periodontally weak teeth.

Primary outcomes:
measure: proximal contacts tightness
timeFrame: immediately after procedure
Secondary outcomes:
measure: Proximal contours and overhangs
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
state: Islamabad Capital Territory
Study officials:
References: