louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00261300: Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
Official title: Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Peptic Ulcers
Keywords: Gastric acid
GERD
Gastroesophageal reflux disease
Pantoprazole
Proton pump inhibitor
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients.

Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum).

The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy of pantoprazole.


Eligibility criteria: Main Inclusion Criteria:

* Patients who completed ALTANA Pharma study BY1023/FK3006 (long-term clinical trial regarding efficacy and tolerability of Pantoprazole in patients not responding to treatment with H2-receptor antagonists or omeprazole)
* Written informed consent

Main Exclusion Criteria:

* Concomitant diseases
* Pregnant or nursing female patients; female patients of childbearing potential who are not using reliable contraception

Primary outcomes:
measure: Safety (adverse events, laboratory values).
timeFrame: 5 years
Secondary outcomes:
measure: Evaluation of gastrointestinal symptoms, histological parameters.
timeFrame: 5 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Altana Pharma/Nycomed
Study officials:
affiliation: 30659 Hannover, Germany
name: Gorig Brunner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01391000: Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
Official title: Light Amplification by Simulated Emission Radiation Carbon Dioxide (Laser CO2) Versus Transcutaneous Electrical Stimulation (TENS) for the Reduction of Pain in Patients After Reconstruction of the Rotator Cuff. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injury
Keywords: rotator cuff surgery
pain
exercise therapy
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy for pain control in the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff.

Detailed description: To evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide for pain control in the post-surgical rehabilitation of patients treated with reconstruction of the rotator cuff and to evaluate, at the end of the rehabilitation period, the range of motion, the function gained and the quality of life comparatively in the two groups of patients treated with Transcutaneous Electrical Stimulation or Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy.

Eligibility criteria: Inclusion Criteria:

* subjects after surgery for rotator cuff injury of traumatic and / or degenerative

Exclusion Criteria:

* concomitant fractures of the humerus, pace-maker, diseases for which treatments are contraindicated.

Primary outcomes:
measure: Visual Analogue Scale Mean Score
timeFrame: Change from baseline in pain at the end of the rehabilitation cycle (two weeks)
Secondary outcomes:
measure: Constant Murley Score for Range of Motion and Shoulder Function Assessment.
timeFrame: Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)
measure: Short Form 12-PCS for Quality of Life Assessment
timeFrame: Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Bo
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Roberta Monesi, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034800: The Neuropsychiatric Evaluation of HIV-Positive and Negative Drug Using Individuals: Study 215
Official title: The Neuropsychiatric Evaluation of HIV-Positive and Negative Drug Using Individuals: Study 215
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV Positive
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2009-12-17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The lack of success in treating substance abuse may be contributed to by a limited understanding of the clinical neurobiology of drug abuse. A better understanding of such deficits might aid in the development of more relevant pharmacological and psychosocial treatment approaches. Thus, the purpose of this study is to test the hypothesis that repetitive illicit drug use may be associated with cortical and subcortical structural abnormalities, vascular abnormalities, as well as neuropsychological decrements. Additionally, a battery of psychological tests are administered to provide information about demographics, drug use, neurocognitive measures, and personality structures....

Detailed description: The lack of success in treating substance abuse may be contributed to by a limited understanding of the clinical neurobiology of drug abuse. A better understanding of such deficits might aid in the development of more relevant pharmacological and psychosocial treatment approaches. Thus, the purpose of this study is to test the hypothesis that repetitive illicit drug use may be associated with cortical and subcortical structural abnormalities, vascular abnormalities, as well as neuropsychological decrements. Additionally, a battery of psychological tests are administered to provide information about demographics, drug use, neurocognitive measures, and personality structures.

Eligibility criteria: * Data analysis protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute on Drug Abuse, Biomedical Research Center (BRC)
state: Maryland
Study officials:
References:
Clinical trial NCT01140100: A Comparative Study of Depth of Anesthesia Monitored by Bispectral Index (BIS) Values
Official title: A Comparative Study of Depth of Anesthesia Monitored by BIS Values in Two Anesthesia Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthetics
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether induction of anesthesia with thiopental followed by propofol infusion is able to maintain sufficient depth of anesthesia .


Eligibility criteria: Inclusion Criteria:

* being adult
* having ASA I or II
* scheduled for elective cataract surgery under general anesthesia

Exclusion Criteria:

* massive obesity
* intake of any central nervous system (CNS) stimulants
* intake of CNS depressants
* intake of Tricyclic antidepressants
* known adverse reaction to the study drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Sina Ghaffaripour, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Hilda Mahmoudi, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03888300: Measurement of Viscoelastic Properties of Bronchopulmonary Secretions.
Official title: VLM-2: Measurement of Viscoelastic Properties of Bronchopulmonary Secretions.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Pulmonary Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive standard physiotherapy as prescribed by the physician
Primary purpose: TREATMENT

Brief summary: The study is experimental and aims to (a) compare the viscoelastic properties of bronchial secretions obtained in patients suffering from obstructive respiratory disease, and (b) to compare the viscoelastic properties of bronchial secretions obtained in patients before and after application of a respiratory physiotherapy or exercise as usually prescribed.

After agreement, the sputum of the participants will be collected according to the method used in clinical routine.Experiments (collection and analysis of sputum) will be conducted at the Saint-Luc University Clinic.


Eligibility criteria: Inclusion Criteria:

* obstructive pulmonary disease

Exclusion Criteria:

* none

Primary outcomes:
measure: Viscoelasticity
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Gregory Reychler, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05005000: Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
Official title: Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Arthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 0
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: 32 patients with Eaton-Glickel stage 2-3 CMC arthritis will be randomized to receive intraarticular MFAT or intraarticular corticosteroid injection. Patients with inflammatory arthritis or prior thumb base trauma or surgery will be excluded. Autologous adipose tissue will be harvested from the outer thigh or lower abdomen using local anesthesia. Tissue will be processed to remove oil and debris in-office using an FDA-approved commercially available device. The processed adipose will be immediately injected into the thumb CMC joint under fluoroscopic guidance. Visual analogue score (VAS), grip/pinch strength, Kapandji range of motion score, thumb disability examination, and QuickDASH score will be assessed pre-procedure and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.


Eligibility criteria: Inclusion Criteria:

1. 18 years old or older; male and female patients
2. Eaton-Glickel stage 2-3 thumb CMC arthritis
3. Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
4. Able to provide informed consent

Exclusion Criteria:

1. Pregnancy/breastfeeding
2. Inflammatory or posttraumatic arthritis
3. Prior thumb base trauma or surgery
4. Evidence of skin infection or soft tissue loss at the thumb CMC joint or adipose harvest site
5. Active local or systemic malignancy
6. Known allergy to any study drug

Primary outcomes:
measure: Percent Change in Score on Pain Visual Analog Scale (VAS)
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Change in Score on Thumb Disability Exam (TDX)
timeFrame: Baseline, Month 12
measure: Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score
timeFrame: Baseline, Month 12
measure: Change in Kapandji Range of Motion Score
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jacques Hacquebord, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04626700: Comparison for Oral Negative Pressure Therapy and CPAP for OSA Under Sleep Endoscopy Assistance: A Randomized Controlled Trial
Official title: Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: OSA
iNAP
DISE
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is the study entitled "Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Recent study reveals that oral negative pressure therapy improves apnea severity in OSA patients with good compliance. However, no study is designed to compare oral negative pressure therapy and CPAP for OSA patients. In addition, the effect of oral negative pressure therapy for hypopharynx is unclear. Therefore, we will perform druginduced sleep endoscopy to evaluate upper airway obstruction of OSA patients before treatment. OSA patients will be assigned into oral negative pressure group or CPAP group for 2 months. Sleepiness, sleep quality, residual apnea severity and compliance will be evaluated.


Eligibility criteria: Inclusion Criteria:

* mild to moderate OSA

Exclusion Criteria:

* hypopharynx obstruction
* ASA classification of physical status)\>3
* allergy toDexmedetomidine
* COPD stage IV
* Asthma with exacerbation
* severe CHF
* age \< 18 year-old
* claustraphobia
* any reason : can not tolerate CPAP
* second or third degree AVB

Primary outcomes:
measure: The Epworth Sleepiness Scale (ESS)
timeFrame: Change from Baseline ESS at 1 month
measure: The Epworth Sleepiness Scale (ESS)
timeFrame: Change from Baseline ESS at 2 months
measure: apnea-hypopnea index (AHI)
timeFrame: Change from Baseline AHI at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Institutional Review Board Chang Gung Medical Foundation
name: Tsang-Tang Hsieh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03897400: Ovarian Reserve in Crohn's Disease
Official title: Evaluation of Ovarian Reserve in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Ovary Disease
Anti-Mullerian Hormone Deficiency
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group consisted of young women in the reproductive age with crohn's disease.

Brief summary: Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian tubes and ovaries and indirectly through surgical interventions and tubal adhesions associated with disease treatment. Anti-mullerian hormone (AMH) is a reliable indicator of ovarian reserve in women. The aim of this study was to compare serum AMH levels in women with Crohn's disease and healthy controls. In this study, the investigators aimed to investigate AMH and ovarian capacity in the study group with crohn's disease and in the control group without disease.


Eligibility criteria: Inclusion Criteria:

* crohn's disease;
* reproductive age women

Exclusion Criteria:

* Over 40 years old,
* a previous ovarian resection;
* renal failure (serum creatinine levels N1.2 mg / dL);suspicion of malignancy;
* the presence of hereditary or acquired hematological disease;
* pregnancy;
* current lactation;
* the presence of a serious comorbid chronic disease;
* cirrhosis originating from chronic liver disease;
* abnormal thyroid function tests;
* a known serious psychological problem;
* presence of alcoholism and male sex.

Primary outcomes:
measure: AMH levels
timeFrame: 1 MONTH
Secondary outcomes:
measure: ultrasound findings
timeFrame: 1 MONTH
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT05093400: Oropharynx (OPX) Salivary Biomarker Study
Official title: Oropharynx (OPX) Salivary Biomarker Study: Microbiome, Virome, and Metabolomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy non-cancerous participants

Brief summary: The goal of this study is to analyze certain biomarkers to look at the relationship between HPV in the saliva, stage at presentation, and a potential self-test compared to saliva of non-cancerous participants.


Eligibility criteria: Inclusion Criteria:

* Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).

Normal Controls:

* Age ≥ 18 years;
* Able to provide informed written consent documenting permission to give saliva sample for research testing.;
* Ability to complete questionnaire(s) by themselves or with assistance.

Exclusion Criteria:

* Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).

Normal Controls:

* Any personal history of head or neck cancer including head or neck skin cancer.
* Other active malignancy ≤ 5 years prior to registration.
* EXCEPTIONS: Non-melanotic skin cancer, non-metastatic prostate cancer.
* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
* Dry mouth (xerostomia) caused by any chronic (\>30 days) condition (known or unknown) or medication.
* Recent (within 30 days) or active upper aerodigestive tract or anogenital infections.

Primary outcomes:
measure: Oncologic strains in HPV DNA salivary samples
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kathryn Van Abel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03576300: Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome
Official title: Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndrome
Diabetes Mellitus Type 2
Keywords: ocular surface
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asian

Brief summary: The study aims to compare the differences of ocular surface features in controls and patients with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of diabetics, and to find out the relationship between dry eye syndrome and diabetes

Detailed description: In this study, we perform a completely comparison of ocular surface characteristic including the Ocular Surface Disease Index (OSDI) questionnaire,tearfilm break up time(BUT),corneal fluorescein scores(CFS),Shirmer test,corneal sensitivity)among diabetic patients with DE, diabetic patients without DE, non-diabetic patients with DE and normal subjects and analysis of EGF, IL-17A, IL-1β, IL-8 and TNF-α in tears and their clinical correlations are also performed to investigate potential biomarkers for diagnosis of diabetic with DE.

Eligibility criteria: Inclusion Criteria:

1. dry eye diagnosis according to Expert's Consensus About Clinical Diagnosis and Treatment（Corneal Disease Group of Ophthalmological Society, Chinese Medical Association）: ①OSDI≥13，②positive dry eye soigns(ST≤10mm/5min；BUT≤10s；CFS\>0)
2. type 2 diabetes diagnosis according to American Diabetes Association：Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
3. Willing to sign the consent form.

Exclusion Criteria:

1. Having known Eye infection, allergy, malformation, abnormal eye movement
2. Exclusion of eye injury, any kind of eye surgery
3. Exclusion of other disease may cause neuropathy or influence tear producing
4. Using systematic or local antibiotics that may influence tear producing

Elimianation Criteria

1. poor compliance
2. voluntary withdrawal
3. any other kind of situation that researchers consider not suitable for further study.

Primary outcomes:
measure: Tear cytokines levels
timeFrame: through study completion,an average of two weeks
Secondary outcomes:
measure: Clinical correlations of the tear cytokines
timeFrame: through study completion,an average of two weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi, MD
role: STUDY_DIRECTOR
References: