louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03174873: Tubal Factor in Unexplained Infertility
Official title: Laparoscopic Tubal Evaluation in Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility of Tubal Origin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Ray and colleagues define "unexplained infertility" as failure to achieve pregnancy when the semen analysis is normal, evidence for ovulation is present, and tubal patency has been established. The efficacy of treatment declines with increasing age and duration of infertility Infertility is a disease , defined by the failure to achieve a successful pregnancy after 12 months or more of appropriate, timed unprotected intercourse or therapeutic donor insemination, barber evaluation and treatment may be justified based on medical history and physical findings and is warranted after 6 months for women over age 35 years.

In unexplained infertility abnormalities are likely to be present but not detected by current methods including semen analysis in the man, assessment of the state of ovulation, ovulation reserve and patency of uterine tubes in the woman.

unexplained infertility is not a rare item of infertility. Approximately 15% of infertility couple will be diagnosed with unexplained infertility after their diagnostic workup Many researches studied the laparoscopic tubal factor like tubo-ovarian relation, tubal kinks and fimbrial pathology. But we need to scope on more tubal factors like fatty mesosalpinx , fimbria ovarica, methylene blue free spill and others


Eligibility criteria: Inclusion Criteria:

* women with unexplained infertility.
* women in reproductive period between 20 and 35 years.
* primary or secondary infertility

Exclusion Criteria:

* with age less than 20 years and more than 35 years old
* other causes of infertility other than tubal factor
* Other contraindications for laparoscopy

Primary outcomes:
measure: Number of Participants will be diagnosed to have tubal cause of infertility by laparoscopy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT03063073: Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block
Official title: Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer Female
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).

Detailed description: 60 patients scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfascial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Eligibility criteria: Inclusion Criteria:

* ASA I - II patients

  * weight 50- 100 kg
* age 18-60 years

Exclusion Criteria:

* History of bleeding diathesis
* Relevant drug allergy
* Opioid dependence
* Sepsis
* Those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study

Primary outcomes:
measure: I.V patient controlled analgesia (PCA) morphine consumption
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: pain relief
timeFrame: 48 hour
Other outcomes:
measure: stress response
timeFrame: 24 hour
Locations:
city: Assuit
country: Egypt
facility: South EGYPT cancer institute
Study officials:
affiliation: manager
name: sahar m abd elbaqy, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00984373: Epidemiology of Schizophrenia in Bulgaria
Official title: Epidemiological Study to Describe Approaches in Diagnosis, Treatment and Social Functioning of Schizophrenic Patients in Bulgaria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia epidemiology
Schizophrenic patients' social and health characteristics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The purpose of this study is to provide accurate, reliable information on schizophrenia clinical management in order to detect unmet medical needs of this disease in terms of:

* Patient characteristics.
* Diagnostic and treatment approaches: initial and subsequent.


Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia
* Above 18 years
* Signed Informed consent

Exclusion Criteria:

* Below 18 years
* Consent refused

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Research Site
city: Pazardzhik
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Vidin
country: Bulgaria
facility: Research Site
Study officials:
References:
Clinical trial NCT05590273: Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers
Official title: Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Caregivers
Neuro-Oncology
Brain Cancer
Keywords: CALM
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
First posted: 2022-10-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study has been designed in accordance with the NIH Science of Behavior Change ORBIT model for developing behavioral interventions and represents a Phase Ia Define Trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To conduct a mixed-method Phase Ia Define Trial of caregivers' participation in CALM therapy with post-session surveys and individual exit interviews in order to evaluate suitability and adapt the CALM intervention to the needs of caregivers in neuro-oncology.

Detailed description: Exploring caregivers' experiences of CALM intervention will inform more effective, targeted, supportive care for this traditionally underserved group in need of emotional support. We will use the data from this study to adapt the CALM intervention to the specific needs of caregivers in neuro-oncology

Eligibility criteria: Inclusion Criteria:

* Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755)
* Fluent in English
* Willing and able to attend a minimum of 3 CALM sessions via telehealth
* A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related
* Patient participants must have enrolled in the linked HM20022755 study

Exclusion Criteria:

* Person does not consider themselves to be a caregiver of the patient
* Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755)
* Caregiver does not speak English
* Caregiver is unable to provide consent
* Caregiver does not have access to telehealth
* Caregiver is under the age of 18
* Professional caregivers who received financial compensation for their services are ineligible

Primary outcomes:
measure: Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction.
timeFrame: 3 months
measure: Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregivers' recommendations to the content and format of the intervention during an exit-interview.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashlee R Loughan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061073: Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial
Official title: Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-oncological Indication to Ureteral Stenting
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 73
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: JJ ureteral stent represents an advance in the management of the upper urinary tract obstruction as it allows the patient to resume his activities although he is stented between the kidney and the bladder.

However, in many cases, this JJ stent is not well tolerated and can even be unbearable.

This trial evaluates the benefit of tamsulosin (an alpha-blocker) in improving the tolerance of JJ stents compared to low-doses of phloroglucinol.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 or more.
2. Non-oncological indication to ureteral stenting
3. Informed written consent

Exclusion Criteria:

1 Any contra-indication to Tamsulosin or phloroglucinol (renal or hepatic insufficiency, allergy) 2. Pregnancy 3. Patients already treated with alpha blockers

Primary outcomes:
measure: Evaluate the benefit of alpha-blockers (Tamsulosin, group A) compared to phloroglucinol (Spasfon®, group B) as regards patients tolerance to JJ stents
timeFrame: 1 month treatment
Secondary outcomes:
measure: incidence of complications
timeFrame: after 1 month treatment
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital - 2 rue de la Milétrie
Study officials:
References:
Clinical trial NCT02276573: Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus
Official title: Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Planus, Oral
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is 1 to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and debilitating is characterized by erosive areas, ulcerated on an erythematous base with or without a keratinocyte lichenien network.

The literature data moving towards an autoimmune origin, but the pathophysiological mechanisms of OLP remain unknown.

This project represents the first part of a comprehensive project to examine the oral pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on Epstein-Barr Virus (EBV).


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years
* Clinical and/or histological diagnosis of erosive or atrophic OLP
* No signs of severe dysplasia at the sampling

Exclusion Criteria:

o immunosuppressive or anti-inflammatory therapies at the inclusion

Primary outcomes:
measure: Measure of level of EBV nucleic acids
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital saint Roch
Study officials:
References:
citation: Raybaud H, Olivieri CV, Lupi-Pegurier L, Pagnotta S, Marsault R, Cardot-Leccia N, Doglio A. Epstein-Barr Virus-Infected Plasma Cells Infiltrate Erosive Oral Lichen Planus. J Dent Res. 2018 Dec;97(13):1494-1500. doi: 10.1177/0022034518788282. Epub 2018 Jul 13.
Clinical trial NCT02078973: Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)
Official title: The Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Circulatory System, During Basal Conditions and During Inhibition of the Nitric Oxide System in Healthy Subjects. A Dose-response Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nephropathy
Keywords: Tolvaptan
L-NMMA
Healthy subjects
Nephrology
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2014-03-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which stimulates V1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones.

The purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA).


Eligibility criteria: Inclusion Criteria:

* Men and women, age 18-40 years
* Body Mass Index (BMI) 18,5-30 kg/m2

Exclusion Criteria:

* Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
* Neoplastic disease
* Drug abuse
* Alcohol abuse
* Medical treatment except peroral anticontraceptive
* Pregnancy
* Smoking
* Abnormal blood and urine sample
* Abnormal ECG
* Blood donation within a month before examination
* Arterial hypertension (\>140 mmHg systolic and/or 90 mmHg diastolic)

Primary outcomes:
measure: CH2O
timeFrame: 5-6 Hours
Secondary outcomes:
measure: Urine biomarkers(Aquaporins and Epithelial Sodium Channels γ)
timeFrame: 5-6 Hours
measure: Central and brachial blood pressure
timeFrame: 5-6 Hours
measure: Augmentation Index
timeFrame: 5-6 Hours
measure: Vasoactive Hormones( Angiotensin II, Aldosterone, Endothelin, Atrial Natriuretic Peptide, Brain Natriuretic Peptide, Arginin Vasopressin)
timeFrame: 5-6 Hours
measure: Fractional sodium excretion
timeFrame: 5-6 Hours
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of medical research
Study officials:
affiliation: Department of medical research
name: Frank H Mose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al Therwani S, Rosenbaek JB, Mose FH, Bech JN, Pedersen EB. Effect of tolvaptan on renal water and sodium excretion and blood pressure during nitric oxide inhibition: a dose-response study in healthy subjects. BMC Nephrol. 2017 Mar 13;18(1):86. doi: 10.1186/s12882-017-0501-1.
Clinical trial NCT02286973: Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty
Official title: Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Degenerative Arthritis
Keywords: Tranexamic acid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 264
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA.

To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.


Eligibility criteria: Inclusion Criteria:

* patients with diagnosis of primary osteoarthritis

Exclusion Criteria:

* patients with diagnoses other than primary OA
* patients on anticoagulation therapy
* patient with chronic renal failure
* patient with CVA Hx
* Patient with seizure Hx
* Patient with severe CHF
* Patient with acquired or congenital coagulopathy

Primary outcomes:
measure: Change in Hemoglobin
timeFrame: baseline and 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00621673: Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
Official title: Assessment of the Risk of Inhibitor Formation in Subjects With Severe Hemophilia A When Switched From a Replacement Therapy With a rFVIII Produced by a Chinese Hamster Ovary (CHO) Cell Line to a rFVIII Produced by a Baby Hamster Kidney (BHK) Cell Line (Kogenate® FS).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemophilia A
Keywords: Hemophilia A,
Inhibitor formation,
rFVIII
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 1
Sex: MALE
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.


Eligibility criteria: Inclusion Criteria:

* Subjects with severe hemophilia A (\< 2% FVIII:C)
* Subjects with no history of FVIII inhibitor antibody formation
* Subjects with no measurable inhibitor activity
* Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in the previous 6 months
* Subjects whose current treatment with any CHO rFVIII product
* Subjects with no elective surgery and/or continuous infusion FVIII administration is foreseen during the study
* Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT) compatible with FVIII deficiency

Exclusion Criteria:

* Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's disease)
* Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS or known hypersensitivity to mouse or hamster proteins
* Any individual with a past history of severe reaction(s) to FVIII concentrates
* Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry
* Subjects who were receiving or had received other experimental drugs within 3 months prior to study entry
* Subjects who require any medication for FVIII infusions

Primary outcomes:
measure: To evaluate whether a switch of replacement therapy from an rFVIII produced in a CHO cell line to an rFVIII produced in a BHK cell line is associated with a risk of inhibitor formation.
timeFrame: 6 months
Secondary outcomes:
measure: To quantify the risk of inhibitor formation, to assess the efficacy of the rFVIII-FS while on regular replacement therapy and to assess the quality-of-life (QoL) before and after the study.
timeFrame: 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04247373: The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum
Official title: The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum in the Patients Undergoing Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Gastrectomy
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.

Detailed description: According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine, the investigators use biased coin design up-and-down method.

Based on the practices, the starting concentration is 0.375 %, and the step size of concentration is 0.125%.

Eligibility criteria: Inclusion Criteria:

* patients undergoing laparoscopic gastrectomy that require pneumoperitoneum
* patients who has epidural catheter to manage postoperative pain control
* patients who agree to our study

Exclusion Criteria:

* patients who don't agree to our study
* BMI\<16.0 or BMI\>35
* cardiovascular disease, pulmonary disease, renal disease
* alcoholic abuser or drug abuser
* any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction

Primary outcomes:
measure: Changes from baseline in heart rate (bpm) after CO2 insufflation
timeFrame: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
measure: Changes from baseline in mean arterial pressure (mmHg) after CO2
timeFrame: immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dongsan Medical Center
name: JIWON LEE, Dr
role: PRINCIPAL_INVESTIGATOR
References: