louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02369614: Low -vs- High-Frequency Repetitive TMS of the Right Dorsolateral Prefrontal Cortex in PTSD
Official title: Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PTSD - Post Traumatic Stress Disorder
Keywords: rTMS - repetitive transcranial magnetic stimulation
CAPS - Clinician Administered PTSD Scale
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2015-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized placebo/sham controlled, double-blind study investigating the efficacy of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.

Detailed description: The study will be carried out within the Overcoming Adversity and Stress Injury Support (OASIS) program administered by Naval Medical Center San Diego (NMSD). OASIS is a residential treatment program developed for active duty service members diagnosed with combat related PTSD. OASIS is a 9 week program in which cohorts of 10 patients undergo a variety of therapeutic activities with a focus on cognitive processing therapy (CPT) of combat trauma conducted in both group and individual formats.

Subjects who qualify will be assigned by block randomization to one of four arms:

1. 1 Hz rTMS of the right dorsolateral prefrontal cortex
2. 10 Hz rTMS of the right dorsolateral prefrontal cortex
3. Sham rTMS of the right dorsolateral prefrontal cortex
4. OASIS treatment as usual

Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .

Eligibility criteria: Inclusion Criteria:

Participant in the OASIS program

Willing and able to give informed consent

Diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS CAPS score of at least 50

Males or females between 18-65 years of age

Exclusion Criteria:

Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Active Substance use

Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety

ECT treatment within the last 30 days Patients with neurological disorder leading to increased intracranial pressure

Participation in other interventional treatment protocols (participants of monitoring/observational studies can be included)

Primary outcomes:
measure: Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NMCSD
name: Donald Hurst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01042314: Drug-Drug Interaction Study With Aricept® (Donepezil)
Official title: A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time


Eligibility criteria: Inclusion Criteria:

* Healthy men and postmenopausal women

Exclusion Criteria:

* Medical History and Concurrent Diseases
* Gastrointestinal disease
* Gastrointestinal bleeding disorders
* History of peptic ulcer disease
* History of cholecystectomy
* History of seizure disorder
* History of asthma
* History of Chronic Obstructive Pulmonary Disease
* History of cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access

Primary outcomes:
measure: Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28
timeFrame: Days 14 and 28
Secondary outcomes:
measure: Aricept® alone and with BMS-708163: Safety and tolerability based on adverse events, ECG, vital signs and safety labs
timeFrame: Days 7, 14, 21, 29 and study discharge
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Parexel International - Baltimore Epcu
state: Maryland
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04020614: Colorectal Cancer Awareness in Turkey
Official title: Assessment of Colorectal Cancer Awareness in Patients Admitted to the General Surgery Outpatient Clinic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Awareness
Screening
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul Training and Researh Hospital
name: Taksim Training and Research Hospital
First posted: 2019-07-16
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who apply to the general surgery outpatient clinic with any diseases.

Brief summary: Colorectal cancer is among the most common types of cancer worldwide. Population-based screening programs for breast, cervical, and colorectal cancer have been introduced as part of cancer control in many high-income countries. Population-based cancer screening programs do not exist in most low- and middle-income countries. There are some studies that report the awareness of colorectal cancer in Turkey.

Detailed description: Colorectal cancer is the third most common type of cancer in both men and women. According to World Health Organization data, in 2012, 694 thousand people were thought to be due to colorectal cancer and this number increased to 862 thousand people in 2018. Especially in most low- and middle-income countries where cancers are mainly detected through very-late-stage symptoms and many are not reported. Recent researches may lead to new approaches to early detection and treatment using improved awareness of the symptomatic disease and population-based screening of asymptomatic people. The increasing of colorectal cancer awareness could help early detection of colorectal cancers. In this study, the investigators aimed to determine the level of awareness of colorectal cancer and knowledge about colorectal cancer screenings in patients who applied to general surgery outpatients clinic where a colorectal cancer diagnosis was most frequently diagnosed.

Eligibility criteria: Inclusion Criteria:

* Patients who apply to the general surgery outpatients clinic

Exclusion Criteria:

* Younger than 18 years old
* Older than 80 years old
* Mental retardation or other mental illness
* Refusing to join the study

Primary outcomes:
measure: The awareness of patients about colorectal cancer
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Coskun Cakir, MD
role: STUDY_DIRECTOR
References:
citation: Andsoy II, Gul A. Breast, cervix and colorectal cancer knowledge among nurses in Turkey. Asian Pac J Cancer Prev. 2014;15(5):2267-72. doi: 10.7314/apjcp.2014.15.5.2267.
citation: Kaya O, Hoca O, Kulacoglu H. Knowledge and awareness of auxiliary health personnel about colorectal cancer. Turk J Gastroenterol. 2013;24(4):339-44. doi: 10.4318/tjg.2013.0631.
Clinical trial NCT05463614: Population Pharmacokinetics of Propafenone and Propranolol in Children Patients
Official title: Population Pharmacokinetics of Propafenone and Propranolol in Children Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children aged 0-18 years and receive treatment with Propafenone and Propranolol

Brief summary: The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol

Exclusion Criteria:

* Patients can not complete the research; Abnormal hepatic and renal function; Patient is allergic to propafenone; There are conditions that researchers do not consider it appropriate to join the research.

Primary outcomes:
measure: Ventricular premature beats of 24 hours
timeFrame: From date of randomization until the date of discharge, assessed up to 12 months
Secondary outcomes:
measure: P-R interval
timeFrame: From date of randomization until the date of discharge, assessed up to 12 months
measure: QT interval
timeFrame: From date of randomization until the date of discharge, assessed up to 12 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei province Children's Hospital
state: Hebei
Study officials:
References:
Clinical trial NCT05666414: Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy
Official title: Assessment of Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy Technique in the Atrophied Posterior Mandible: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 7
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess the efficiency of the computer-guided interpositional sandwich osteotomy for the vertical bone gain and effects on vital structures (inferior dental nerve bundle) compared to free hand interpositional osteotomies.

Detailed description: in this research a full digital sandwich osteotomy protocol was conducted to be compared with the conventional protocol. the investigators were seeking to determine the significance of using surgical computer software in sandwich interpositional bone grafting at atrophied posterior mandibles and how efficiently can it affect this technique.

Eligibility criteria: Inclusion Criteria:

* • Edentulous posterior mandibular ridge with vertical loss of alveolar bone with remaining bone height (4-7 mm) above the mandibular canal

  * Good oral hygiene
  * Highly motivated patients
  * Patients seeking fixed prosthesis at posterior mandibular region.
  * Patients willing for a surgical procedures follow-up with an informed consent
  * Age range 20-65 years

Exclusion Criteria:

* • Smokers

  * Individuals with dentulous posterior mandible ridge
  * Medically compromised patients
  * Patients with local pathosis at the surgical area suggested
  * Previously subjected to reconstructive procedures of the posterior mandible

Primary outcomes:
measure: amount of vertical bone gain
timeFrame: 4 months
Secondary outcomes:
measure: neurosensory affection
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future University in Egypt
state: New Cairo
Study officials:
affiliation: university
name: ahmed k mohamed, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01087814: Sustiva Levels With Use of a Gel Capsule
Official title: Effect of Encapsulation Upon Efavirenz Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
HIV Infections
Keywords: efavirenz
Sustiva
pharmacokinetics
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.


Eligibility criteria: Inclusion Criteria:

* HIV-negative, proven by ELISA
* Age: ≥ 18 years old

Exclusion Criteria:

* Psychiatric or psychological illness that would make adherence to protocol procedures unlikely.

Primary outcomes:
measure: Serum Levels of Efavirenz
timeFrame: 5th day of taking drug
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Timothy W Schacker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01893814: Benefit and Tolerability of a Probiotic Product in Infants With Abdominal Discomfort
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Abdominal Discomfort
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2013-07-09
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate benefit and tolerability of a probiotic product in infants with abdominal discomfort.


Eligibility criteria: Inclusion Criteria:

* Male or female singleton
* ≥ 2 weeks and ≤ 12 weeks of age
* Exclusively breastfed at screening
* Abdominal discomfort (infant colic) in the week prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
* Episodes of fussy crying that lasted at least 3 hours a day for at least 3 days in the 7 days prior to enrollment, according to the statement of the parent(s) and/or guardian(s)
* Voluntary, written informed consent of the parent(s) and/or guardian(s) to participate in the study
* Born at full term (37-42 after last menstruation period)
* Birth weight: 2500 - 4500 g
* Weight-for-age ≥ 3th and ≤ 97th percentile according to WHO growth tables / charts
* Apparently healthy at birth (Apgar ≥ 8) and at screening visit
* No major complications during pregnancy or at birth
* Mother 19-45 years of age at childbirth
* Ability of parent(s) and/or guardian(s) to attend visits, interviews and willingness to fill out questionnaires

Exclusion Criteria:

* Intolerance to investigational product/its ingredients
* Severe medical condition or illness, congenital abnormality
* Gastrointestinal disorders (e.g. reflux esophagitis)
* Intake of probiotics and/or antibiotics in the week preceding recruitment and during the study
* Formula feeding at screening/randomisation
* Allergy or atopic disease (family history)
* Participation in another study
* Mother's health condition that may interfere with her ability to take care of her infant
* Mother affected by hepatitis B, HIV or Guillain-Barré Syndrome
* Use of antibiotics by the mother in the week

Primary outcomes:
measure: Reduction of abdominal discomfort as assessed by comparison of crying time
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Virchow Hospital
Study officials:
References:
Clinical trial NCT01191814: Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression
Official title: A Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Jaundice
Pancreatic Cancer
Keywords: pancreatic cancer
obstructive jaundice
Obstructive jaundice secondary to pancreatic cancer
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2010-08-31
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Detailed description: Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer as there will be better drainage of the obstructed biliary system with fewer adverse events.

Eligibility criteria: Inclusion Criteria:

* Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
* Patients 19 yrs of age and older
* Serum bilirubin \> 2mg/dl
* CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).

Exclusion Criteria:

* Karnofsky score \< 60
* Prior (ERCP or PTC) attempts at biliary decompression for the same indication
* Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day)
* Ongoing or planned neoadjuvant therapy
* Cholangitis at presentation or coagulopathy needing reversal medication
* Post-surgical anatomy
* Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
* Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).

Primary outcomes:
measure: Complications related to stent dysfunction
timeFrame: 30 days
Secondary outcomes:
measure: Procedural complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
Study officials:
affiliation: AdventHealth
name: Muhammad Hasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023514: Lipoic Acid Supplementation in IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Women Infertility
Keywords: Oocyte donation
IVF
Lipoic acid
Implantation rate
Endometrial receptivity
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 172
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: Alpha-Lipoic Acid (ALA) is a natural molecule that can make a significant contribution to the success of embryo implantation phase, because it exerts, directly or indirectly, an immunomodulatory activity. ALA has the ability to regenerate antioxidants molecules that facilitate embryo implantation, and to stimulate the production of local mediators useful for implantation. This study is a prospective clinical trial and aims to evaluate the reproductive outcomes of Italian couples following oocyte donation fresh cycles when receiving per os tablets of lipoic acid. Indeed, the control group had only the standard treatment (vaginal progesterone), whereas the study group, in addition to that, received ALA (300 mg, 2 times per day) by oral route, from the day of donors oocyte pick up until the pregnancy test. If the childbearing occurred, treatment continued until the 8th week of pregnancy. Primary outcome of the study is the implantation rate while the positive hCG rate, the clinical pregnancy rate, the miscarriage rate and the live-birth rate are secondary outcomes .


Eligibility criteria: Inclusion Criteria:

Donors:

* Proof of fertility;
* ⩽32 years old
* BMI \<30 kg/m2
* Regular menstrual cycles of 25-33 days
* Two normal ovaries based on transvaginal scan findings.

Recipients:

* Women with infertility problems
* ⩽50 years old,
* BMI \<34 kg/m2

Exclusion Criteria:

Donors:

* Polycystic ovaries
* Endometriosis
* Gynaecological or medical disorders.

Recipients:

* Endocrinologic problems
* Medication for chronic illness
* Azoospermic partner that require TESE
* Sperm donation cycles

Primary outcomes:
measure: Number of implants per cycle
timeFrame: Within 7 weeks after blastocystis transfer
Secondary outcomes:
measure: Number of biochemical pregnancies per group
timeFrame: Within 7 weeks after blastocystis transfer
measure: Number of clinical pregnancies per group
timeFrame: 7 weeks of gestation
measure: Number of live birth per group
timeFrame: At delivery
measure: Number of miscarriage per group
timeFrame: Within 22 weeks of gestation
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Iakentro Advanced Medical Centre, IVF Unit
Study officials:
References:
citation: Monastra G, De Grazia S, Cilaker Micili S, Goker A, Unfer V. Immunomodulatory activities of alpha lipoic acid with a special focus on its efficacy in preventing miscarriage. Expert Opin Drug Deliv. 2016 Dec;13(12):1695-1708. doi: 10.1080/17425247.2016.1200556. Epub 2016 Jun 24.
citation: Cha J, Sun X, Dey SK. Mechanisms of implantation: strategies for successful pregnancy. Nat Med. 2012 Dec;18(12):1754-67. doi: 10.1038/nm.3012.