louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06176521: Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse
Official title: Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: sacrocolpopexy
sacrohysteropexy
pelvic organ prolapse
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-19
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: before and after surgery results of a single group
Primary purpose: TREATMENT

Brief summary: Evaluation of the anatomical and functional results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without using mesh in the surgical treatment of pelvic organ prolapse


Eligibility criteria: Inclusion Criteria:

1. being 18 years old or older
2. needing an operation for symptomatic pelvic organ prolapse -

Exclusion Criteria:

1. past history of chemotherapy or radiotherapy
2. past history of pelvic organ prolapse surgery
3. if there is a contraindication of laparoscopy -

Primary outcomes:
measure: Pre and post operative assessment of POP-Q measurements
timeFrame: 1 year
measure: Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
References:
Clinical trial NCT05126121: Efficacy and Safety of 14-day Concomitant Therapy for Difficult-to-Treat Helicobacter Pylori Infection
Official title: Efficacy and Safety of 14-day Concomitant Therapy for Difficult-to-Treat Helicobacter Pylori: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Concomitant Therapy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the treatment of Hard-to-treat Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates

Detailed description: Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.

This study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 with persistent H. pylori infection.
* Patients failed at least three different standard eradication therapies before.Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, vonoprazan,bismuth and antibiotics in the previous 4 weeks.
* Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
* History of allergy to any of the drugs used in the study.
* Severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
* Currently pregnant or lactating.
* Severe neurologic or psychiatric disorders.
* Alcohol abuse or drug addiction.
* Patients with compliance lower than 90% in any previous treatment are not included.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: Eradication rates
timeFrame: 6 month
Secondary outcomes:
measure: The rate of adverse events happening
timeFrame: 6 month
measure: Compliance of patients
timeFrame: 6 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Study Principal investigator
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05533021: Meleis's Transition Theory on Postpartum Difficulties and Quality of Life in Primipara Mothers
Official title: Impact of the Training Structured According to Meleis's Transition Theory on Postpartum Difficulties and Quality of Life in Primipara Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Care
First Birth
Cesarean Section
Keywords: Depression
Difficulty
Meleis's Transition Theory
Postpartum Period
Primipara Mother
Quality of Life
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2022-09-08
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled experimental study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The randomized controlled experimental study sought to determine the impact of the training structured according to Meleis's Transition Theory on postpartum difficulties and quality of life in primipara mothers.

Detailed description: In the study, the intervention group (39 mothers) was given face-to-face training in the hospital, which was structured according to Meleis' Transition theory, 24 hours after the cesarean section.Telephone counseling was provided on the 5th, 15th and 42nd days after discharge. Thus, these mothers were followed up 4 times in the postpartum period. No intervention was made in the control group (40 mothers).

Eligibility criteria: Inclusion Criteria: Mothers with the following criteria were included in the study;

* Primiparous
* Cesarean delivery
* Over 18 years old
* At least primary school graduate
* Communicating verbally
* Using mobile phone and whatsapp application
* Married and living with spouse

Exclusion Criteria: Mothers with the following criteria were excluded from the study;

* Having a risky pregnancy history
* Having a history of chronic disease
* Diagnosed with a psychiatric illness
* Having a health problem in herself or her baby that requires separation from each other
* Having a baby with any congenital anomaly or severe disease detected at birth

Primary outcomes:
measure: Change in the level of difficulty in self-care of primipara mothers in post-cesarean (42 days)
timeFrame: 1st follow-up (pre-training), 2nd follow-up (post-cesarean 5th day), 3rd follow-up (post-cesarean 15th day) and 4th follow-up (post-cesarean 42nd day)
measure: Change in the level of difficulty in baby-care of primipara mothers in post-cesarean (42 days)
timeFrame: 1st follow-up (pre-training), 2nd follow-up (post-cesarean 5th day), 3rd follow-up (postcesarean 15th day) and 4th follow-up (postcesarean 42nd day)
measure: Postpartum depression
timeFrame: Post-cesarean 42nd day
measure: Postpartum quality of life
timeFrame: Post-cesarean 42nd day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa University
Study officials:
affiliation: Tokat Gaziosmanpasa University
name: Ayla KORKMAZ, Asst.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05123521: Drug Abuse Among Elective Surgeries: an Observational Study.
Official title: Incidence of Drug Abuse at the Cairo University Teaching Hospital Among Patients Who Underwent Elective Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Abuse
Keywords: drug abuse
Cairo Teaching Hospital
elective surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: those who had presented to the General Surgery or Orthopaedics Departments

Brief summary: Drug abusers and addicts form a challenge to the anesthetist because of the added potential risks involved in the administration of anesthesia to this subset of patients, including potential unforeseen drug-drug interactions. In this study, we aimed at screening all patients scheduled for elective orthopedic or general surgeries at the Cairo University Teaching Hospital during a set period of time for the most commonly abused drugs in Egypt.

Detailed description: All patients included in the study consented to take part in this study. Each patient was asked to answer a questionnaire and submit a urine sample in order to be screened for the most commonly abused drugs in Egypt (hashish, tramadol, benzodiazepine, and morphine). Patients were then followed up both intra and post-operatively. Values of patient vital signs, Richmond Agitation-Sedation Scale (RASS) scores as well as clinical recovery scores (CRS) were all diligently recorded and analyzed.

Eligibility criteria: Inclusion Criteria:

* male or female patients classified as American Society of Anaesthesiology (ASA) I or II patients
* patients between 15 and 60 years of age
* patients scheduled for elective surgery.

Exclusion Criteria:

* emergency surgery
* those with disturbed conscious levels
* history of psychological illness
* who refused to give consent

Primary outcomes:
measure: urine analysis
timeFrame: THREE MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Hassan Ali, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06810921: Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin
Official title: Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin: Evaluation of Graft Volume Changes Based on CBCT Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lateral Sinus Lifting
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background:

In sinus augmentation procedure, graft resorption remains a major dilemma of various graft materials.

Objective:

To estimate the graft volume changes following lateral sinus augmentation utilizing cone beam computed tomography.

Methods: A total of 34 lateral sinus augmentation operations were performed and 50 dental implants were concomitantly inserted. The sinus augmentation cases were distributed randomly into 3 groups according to graft material: Group A comprised utilizing deproteinized bovine bone alone, group B using deproteinized bovine bone mixed with leukocyte and platelet-rich fibrin, and group C employing deproteinized bovine bone mixed with advanced platelet-rich fibrin. Cone-beam computed tomography was obtained 2 weeks (baseline record) and 24 weeks postoperatively for the measurement of the graft volume changes.


Eligibility criteria: Inclusion Criteria:

* requiring lateral sinus lift for implant placement

Exclusion Criteria:

* available bone permits implant placement without need for sinus lifting

Primary outcomes:
measure: Evaluation of graft volume changes based on CBCT imaging
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bab Al Muadham
country: Iraq
facility: College of Dentistry
state: Baghdad
Study officials:
References:
Clinical trial NCT05837221: Microbiome in Head and Neck Squamous Cell Carcinoma
Official title: Role of Human Microbiome in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lip Cancer
Oral Cancer
Pharynx Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We aim to enroll 60 patients total - 30 with oral squamous cell carcinoma (OSCC) who are treatment naïve, and 30 who are non-OSCC control patients, who will be age matched to their OSCC counterparts. Estimates show that Dr. Goddard's practice sees approximately 3 treatment naïve OSCC cases per month. We estimate that we can enroll 30-40 of these cases and an equal number of controls in the first 18 months of this study.

Brief summary: This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.

Detailed description: HNSCCis a lethal cancer with a 5-year survival rate below 50%. Although smoking, alcohol intake, and human papillomavirus (HPV) infection are linked to HNSCC, only a small proportion of individuals exposed to these factors develop cancer and not all cases progress. Thus, additional environmental or host factors must contribute to HNSCC. The Study Team and others have observed significant oral dysbiosis in human HNSCC cases, both before and after treatment. This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.

Eligibility criteria: Inclusion Criteria:

1. Subjects equal to or above the age of 18.
2. Patients who are seen and evaluated by a provider within the adult Otolaryngology clinic at the University of Colorado Health.
3. Patients that present with a diagnosis of OSCC.
4. An equal number of age-matched patients who are visiting the clinic for reasons other than OSCC diagnoses, as the control group.
5. Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

1. Subjects under the age of 18 or over the age of 100
2. Subjects unwilling to particiapte

Primary outcomes:
measure: Characterize human dysbiosis
timeFrame: Day 1
measure: Characterize human metabolomics
timeFrame: Day 1
measure: Integrative multi-omic data analysis and biomarker discovery
timeFrame: Day 365
Secondary outcomes:
measure: Impact of human dysbiosis on OSCC development in mice
timeFrame: Day 10-Day 100
measure: Monitor tumor size
timeFrame: Day 10-Day 100
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Shi-Long E Lu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06599021: Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention
Official title: Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Intervention
Ageing
Keywords: Dysphagia
Age-related dysphagia
Health-related quality of life
Dysphagia intervention
Dysphagia characteristics
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 99
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: Participants included in SCAPIS2 (Swedish Cardio Pulmonary bioimage study) are screened regarding swallowing difficulty using a timed water swallow test. Participants who show signs of swallowing difficulty (dysphagia) are included in the present study, which encompasses s flexible endoscopic evaluation of swallowing function (FEES). Participants showing a moderate-severe dysphagia are randomized into one of three intervention groups: muscle strengthening training, skill-based swallowing training and a control group who will receive compensatory treatment. The study is expected to improve diagnostics and treatment of swallowing difficulties in an ageing population.


Eligibility criteria: Inclusion Criteria:

* Participation in SCAPIS2
* Swallowing dysfunction according to timed water swallow test or
* Swallowing dysfunction according to self-report

Exclusion Criteria:

* Severely impaired intellectual abilities.
* Inability to consent to inclusion in the study.
* Inability to answer written questionnaires in Swedish

Inclusion of non-dysphagia control cohort: No signs of aspiration, slow swallowing (\&lt;10 ml/sec) or self-rated difficulties with eating and swallowing in sub-study SCAPIS2

Primary outcomes:
measure: Penetration-aspiration score (PAS)
timeFrame: Baseline to post-intervention (6 weeks)
Secondary outcomes:
measure: Dysphagia related symtoms
timeFrame: Up to 12 months post-intervention
measure: Tongue strength
timeFrame: Up to 12 months post-intervention
measure: Body composition
timeFrame: Up to 12 months post-intervention
measure: Cost of intervention
timeFrame: Up to 12 months post-intervention
measure: Self-perceived swallowing function
timeFrame: Up to 12 months post-intervention
measure: Quality of Life
timeFrame: Up to 12 months post-intervention
measure: Quality of Life
timeFrame: Up to 12 months post-intervention
measure: Assessment of swallowing efficiency
timeFrame: Up to 12 months post-intervention
measure: Assessment of secretion
timeFrame: Up to 12 months post-intervention
measure: Assessment of swallowing initiation
timeFrame: Up to 12 months post-intervention
measure: Assessment of overall swallowing function from the FEES
timeFrame: Up to 12 months post-intervention
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT03018821: The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B
Official title: Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B， Chronic
Lead sponsor: Xi'an Traditional Medicine Hospital
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on chronic hepatitis B.


Eligibility criteria: Inclusion Criteria:

* 18\<=age at treatment\<=65 years old
* Was diagnosed as chronic hepatitis B (ICD10:K73.901) and one of the following Chinese syndromes: hypochondriac pain (TCD:BNG010), jaundice(TCD:BNG020) or abdominal mass (TCD:BNG040).

Exclusion Criteria:

* Combined with other virus hepatitis or alcoholic hepatitis
* Combined with autoimmune disease
* Combined with liver cancer or cirrhosis
* Combined with severe hepatitis with or without complications
* Combined with unstable cardio-cerebrovascular disease
* Combined with severe lung, kidney, endocrine system, nervous system and hematological system diseases
* Combined with Tuberculosis
* Chronic hepatitis patients with ongoing INF treatment
* Woman with pregnancy or breasting feeding
* Mental disorder and can not express self clearly
* Cannot speak Chinese
* Allergic constitution or allergy to multiple drugs
* Refuse to enroll into the study

Primary outcomes:
measure: Traditional Chinese Medicine symptom scale
timeFrame: Change of TCM symptom scale between baseline and sixth months of treatment
Secondary outcomes:
measure: The change of liver fibrosis
timeFrame: Chnage of liver fibrosis between baseline and 6th months of treatment
measure: Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B
timeFrame: Overall effectiveness of treatment between baseline and 6th months of treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Traditional Medicine Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT00626821: Coloplast DialogueStudy
Official title: An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stoma
Keywords: Stoma
Ostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 3017
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

Detailed description: It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.

Eligibility criteria: Inclusion criteria

* Signed informed consent before any study related activities
* Subjects with a colostomy, ileostomy or urostomy
* Subjects must have had their ostomy for at least 6 months
* Subjects must have mental capacity to understand the study and questionnaires
* Subjects must be at least 18 years of age.

Exclusion criteria

* Women who are pregnant or breast-feeding
* Subjects who have more than one ostomy
* Subjects with an ostomy who use plug
* Participation in other studies at the same time
* Previous participation in this study

Primary outcomes:
measure: Quality of Life (Scale 0(Worst)-100(Best))
timeFrame: 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Restored Images
state: Missouri
Study officials:
affiliation: Herlev Hospital, Dep of colorectal surgery
name: Birgitte D Andersen, RN
role: PRINCIPAL_INVESTIGATOR
References: