louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04719754: Epidemiology of Abnormal Vaginal Discharge During Pregnancy
Official title: Epidemiology and Clinico-investigative Study of Abnormal Vaginal Discharge During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginal Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 164
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: Vaginitis among women of childbearing age is well acknowledged as a public health concern due to its high occurrence. Vulvovaginitis is a disorder of the vulva and/or vagina caused by infection, inflammation, or changes in the flora.

There are many types of infections that affect the vagina, the most common three types of infection: bacterial vaginosis, trichomoniasis, and candidiasis. Bacterial vaginosis is the most common vaginal infection in women of reproductive age causing thin and milky vaginal discharge with a fishy odor. Trichomoniasis causes a frothy, greenish-yellow discharge with a foul smell.

Vaginal Candidiasis is one of the most common fungal infections of the female genital tract and the second most common vaginal infection affecting women of reproductive age (after the bacterial infection worldwide. It affects more than 75% of women at least once in their lifetime, with approximately 50% of them also suffering a single recurrence.

About 75% of patients suffering from candidiasis are asymptomatic, but it may be symptomatic with clinical picture characterized by itching, vaginal pain, vulvar burning sensation, dyspareunia, dysuria and mildly unpleasant odor, erythema and vulvar edema, white-yellowish plaques on the walls of the vagina and cervix and cheesy vaginal discharge. The risk of vulvo-vaginal candidiasis increases by 30% during pregnancy also in pregnancy, the presence of vaginitis is related to abortion, intrauterine infection, fetal growth retardation, premature rupture of membranes, preterm birth, low birth weight, puerperal infection, and other adverse pregnancy outcomes.


Eligibility criteria: Inclusion Criteria:

* At any gestational age
* Age of patient: 19-40

Exclusion Criteria:

* Women in labor
* Women with current vaginal bleeding
* Women with current preterm rupture of membrane
* Women immunocompromised women
* Women patients who refused to participate in the study

Primary outcomes:
measure: The prevalence of microorganism in the vaginal discharge during pregnancy.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health Hospital - Assiut university
Study officials:
affiliation: Woman's Health Hospital- Assiut university
name: Ahmed K Ibrahim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03903354: Intraoperative Hyperglycemia and Infections After Orthopedic Surgery
Official title: Relationship Between Severe Intraoperative Hyperglycemia and Infections Within 7 Days After Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Hyperglycemia
Postoperative Infection
Orthopedic Patients
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We are enrolling orthopedic patients undergoing surgery.

Brief summary: Postoperative infections are a common complication. A relationship between perioperative severe hyperglycemia and postoperative infections has been found in patients undergoing craniotomy. The aim of this study is to evaluate the epidemiology of intraoperative severe hyperglycemia (BGC \>180 mg/dL; 10 mmol/L) and postoperative infections (wound, urinary and prosthetic joint infection) and to investigate if severe intraoperative hyperglycemia is associated with an higher risk of early postoperative (within the 7th postoperative days) infections (wound, urinary and prosthetic joint infection).


Eligibility criteria: Inclusion Criteria:

* Orthopedic patients

Exclusion Criteria:

* Non-orthopedic patients

Primary outcomes:
measure: Severe hyperglycemia and incidence of infection
timeFrame: Follow up of the patients for 7 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza
state: RM
Study officials:
References:
Clinical trial NCT02656654: COrporeal Compression at the ONset of Severe Sepsis and Septic Shock
Official title: Pilot Study to Evaluate the Efficacy of and the Tolerance to a Body Bandage to Maintain Fluid Balance in Patients With Severe Sepsis or in Septic Shock in an ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis or Septic Shock
Fluid Resuscitation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Early and adequate fluid resuscitation (\< 6 hours) in patients with circulatory failure is essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably in patients with acute renal failure. Improving fluid balance is considered crucial in the management of patients in septic shock, but the efficacy of the measures currently proposed (diuretics associated or not with albumin and/or dialysis) is controversial. The investigators hypothesize that a whole-body compression using a body bandage could reduce capillary leakage and thus lead to faster restoration of a normal transmural pressure gradient in postcapillary venules and improve venous return.

This is the first study to evaluate mechanical compression using a body bandage to reduce oedema in septic shock.

To do this, a whole-body compression will be set up within the 12 hours following admission. Water balance will be monitored daily throughout the duration of the compression and vital status of patients will be search at 7 days, 28 days and 90 days.


Eligibility criteria: Inclusion Criteria:

* Written informed consent from a person of trust,
* Patients aged 18 years or over,
* Admitted to a Medical ICU for less than 24 hours,
* For severe sepsis or septic shock and requiring fluid resuscitation because of hypotension and/or persistent signs of circulatory shock,
* On mechanical ventilation with orotracheal intubation,

Exclusion Criteria:

* Person not covered by national health insurance
* Recent abdominal or pelvic surgery,
* Contra-indication for a body bandage (PAD, Compartment Syndrome, acute rhabdomyolysis, wounds),
* Pregnant women,
* Patients with severe sepsis or septic shock for more than 24 hours,
* Patients who are moribund or in whom death is probably imminent (within 24h),
* Patients who have given instructions not to be resuscitated,
* Patients under ward of court.

Primary outcomes:
measure: Fluid balance
timeFrame: At 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chalon sur Saône
country: France
facility: CH Chalon sur Saône
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References:
Clinical trial NCT03837054: Does Chemotherapy Train the Mutation of the Pig-A Gene? (PIGA)
Official title: Does Chemotherapy Train the Mutation of the Pig-A Gene?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The PIG-A gene (in humans)/Pig-a (in rodents) may be a useful reporter of acquired gene mutation. A simple and reproductive test based on flow cytometry allows detection of Pig-a mutants in a few minutes with low blood volumes. Many studies in rodents showed that detecting Pig-a mutations is useful for identifying genotoxic exposure, but studies are needed in humans to validate this biological marker. The investigators propose to carry out a study to assess the prevalence of PIG-A mutated reticulocytes among 30 patients exposed to genotoxic chemotherapy for breast cancer treatment. The investigators will prospectively collect, for each patient, 4 blood samples of 10mL during chemotherapy: the first one (T0) before chemotherapy (before genotoxic exposure), T1 during treatment (after the third cure), T2 (just at the end of chemotherapy) and T3 (five weeks after the end of chemotherapy). PIG-A mutated cells frequency distributions will be compared between T0, T1, T2 and T3. At the same time, the investigators will document the impact of such a genotoxic exposure using the micronuclei test on in vitro binucleate lymphocytes. The micronuclei test reveals structural or numerical chromosome aberrations caused by aneugenic or clastogenic exposure. This test will be done on T0 and T3 blood samples of each patient.


Eligibility criteria: Inclusion Criteria:

* Major patients
* Patients with breast cancer
* Who have benefited from breast surgical treatment and have a poly-chemotherapy adjuvanted by FEC100 and Docetaxel.
* Patients should be able to read and understand French.

Exclusion Criteria:

* Minor Patients
* Pregnant women
* Patients who do not speak French and/or are unable to read and understand French.
* Patients who have had a history of radiotherapy, including those who have received a per-operative radiation therapy as part of the initial management of breast cancer
* Patients who have had a history of chemotherapy outside of the chemotherapy possibly received in the treatment of current breast cancer.

Primary outcomes:
measure: analysis of the frequency of reticulocytes PIG-A mutated
timeFrame: 24 months
measure: analysis of the binucleated cell micronuclei frequency in culture
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: : Service de Gynécologie Obstétrique Hôpital Nord
state: Marseille Cedex 20
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean Olivier Arnaud, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02011854: Acupuncture for Post-stroke Shoulder-hand Syndrome
Official title: Acupuncture and Traditional Chinese Medicine Combined With Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome in Community Hospital: a Multicenter，Randomized，Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Shoulder-hand Syndrome
Keywords: acupuncture，rehabilitation,Shoulder-hand Syndrome
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2013-12-13
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor of limb function recovery.This research aims to observe the effect and safety of Acupuncture and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community hospital.


Eligibility criteria: Inclusion Criteria:

- Ischemic stroke and shoulder hand syndrome,conscious,For 2 weeks to 6 months,Patients with I or Ⅱ period.

Exclusion Criteria:

- Disturbance of consciousness,With shoulder joint disease or muscle disease,Patients with shoulder hand syndrome Ⅲ period,Serious primary diseases such as heart,liver and kidney,Mental illness.

Primary outcomes:
measure: Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS)
timeFrame: 4 weeks and 8 weeks after treatment
Secondary outcomes:
measure: Fugl-Meyer scale
timeFrame: 4 weeks and 8 weeks after treatment
Other outcomes:
measure: Barthel index (BI)
timeFrame: 4 weeks and 8 weeks after treatment
Locations:
city: Shanghai
country: China
facility: Pudong New Area TCM Hospital
state: Shanghai
Study officials:
affiliation: Pudong New Area TCM Hospital
name: Huang Zouqin, Dcctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00264654: Long-term Study Of Paroxetine in Women and Men
Official title: Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Social Phobia
Keywords: Social
(SAD)
Anxiety
Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)


Eligibility criteria: Inclusion criteria:

* Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.
* Must give a written informed consent.
* If the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
* Patients have a minimum score of 60 on the LSAS total score.

Exclusion criteria:

* Patients primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24 weeks before week -2.
* Patients with a history or complication of schizophrenia and bipolar disorder
* Patients with a complication of body dysmorphic disorder.
* Patients with evidence of substance abuse (alcohol or drugs).
* substance dependence by DSM-IV-TR criteria within 24 weeks before week -2.
* Patients who started psychotherapy and cognitive-behavioural therapy within 24 weeks before week-2, except for supportive psychotherapy.
* Patients receiving electro-convulsive therapy (ECT) within 12 weeks before week -2.
* Patients being pregnant, lactating or are of childbearing potential and are likely to become pregnant.
* Patients with 3 or more points of HAM-D Item No. 3, or who are likely to attempt suicide.
* Patients with a history or complication of cancer or malignant tumor.
* Patients receiving MAO inhibitors (FP®) within 14 days before expected week 0 visit date.

Primary outcomes:
measure: Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
timeFrame: 52 Weeks
Secondary outcomes:
measure: Proportion of patients responding with a CGI Global Improvement Item. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment.
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04182854: Use of Diuretics in Maintenance Hemodialysis Patients Undergoing Bioimpedance-guided Fluid Management
Official title: Use of Diuretics in Maintenance Hemodialysis Patients With Residual Renal Function Undergoing Bioimpedance-guided Fluid Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diuretic Abuse
Keywords: furosemide
hydrochlorothiazide
residual renal function
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background.The objective of the present study is to verify whether using diuretics will improve either blood pressure or fluid overload in maintenance hemodialysis patients with residual diuresis kidney function.

Detailed description: Methods.46 maintenance hemodialysis patients will be given three stages of diuretic intervention: 100mg furosemide every day for 1 month, 200mg furosemide every day for 1 month, and 100mg furosemide combined with 25mg hydrochlorothiazide every day for 1 month. The 24-hour urine volume, 24-hour urine sodium, 24-hour urine potassium, blood pressure, OH(overhydration) and dry weight will be collected. OH will be measured by bioelectrical impedance.

Eligibility criteria: Inclusion Criteria:

* maintenance hemodialysis patient
* unrine volume more than 100ml.

Exclusion Criteria:

* myocardial infarction;
* unrine volume less than 100ml.

Primary outcomes:
measure: urine volume increasing after diuretic use in maintenance hemodialysis patients with residual renal function
timeFrame: up to 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University internation Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03507153: Muscle Activity Evaluation of Maxillary Bilateral Bounded Partial Denture Fabricated By Bre-Flex Versus Peek
Official title: Muscle Activity Evaluation of Maxillary Bilateral Bounded Partial Denture Fabricated By Bre-Flex Versus Peek (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Class III Modification I Edentulous Patients
Keywords: "Nylon denture base" and "PEEK partial denture"
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph.


Eligibility criteria: Inclusion Criteria:

* All patients must have Kennedy class III modification I upper partially edentulous ridges.
* The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
* All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
* Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
* Free from any tempro-mandibular joint disorder.
* The patients have good oral hygiene and low caries index.

Exclusion Criteria:

* Patients having abnormal habits as bruxism or clenching.
* Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
* Teeth with compromised bone support.
* Patient with xerostomia or excessive salivation.
* Patient with abnormal tongue behavior and/or size.

Primary outcomes:
measure: Muscular activity
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00813553: Effect of β-alanine Supplementation on Muscle Carnosine
Official title: Effect of Two 8-week β-alanine Supplementation Protocols on Muscle Carnosine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: physical fitness
exercise
amino acid
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: University of Bern
name: Insel Gruppe AG, University Hospital Bern
First posted: 2008-12-23
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Carnosine is a natural acid buffering substance of muscle. The primary objective of this study is to test whether a nutritional supplement of beta-alanine enhances carnosine content in muscle.

Detailed description: Volunteers will be randomized to receiving 3 nutritional supplements. Two supplements contain beta-alanine at different doses, the third supplement is a placebo.

Eligibility criteria: Inclusion Criteria:

* Stable health as evaluated by medical evaluation
* Body mass index higher than 18 kg/m2
* Body mass index lower than 25 kg/m2, unless body fat is less than 20%

Exclusion Criteria:

* intolerance to β-alanine,
* allergy to soy, fish and crustacean
* participation in another intervention study
* consumer of dietary supplement susceptible to contain beta-alanine
* determined to have very high baseline muscle carnosine concentration

Primary outcomes:
measure: muscle carnosine concentration
timeFrame: 0 to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University and Inselspital
Study officials:
References: