louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01219166: Is Routine Cholecystectomy Reasonable in All Patients Receiving a Bypass Procedure: a Comparative Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Given Indication for Gastric Bypass Procedure
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Given indication for laparoscopic Roux-en-Y-gastric bypass

Brief summary: Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim of this study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic RYGB.


Eligibility criteria: Inclusion Criteria:

* All patients who received a laparoscopic Roux-en-Y-gastric bypass

Exclusion Criteria:

* previous CCE
* open gastric bypass procedure
* previous bariatric procedure other than gastric banding
* patients lost to follow up

Primary outcomes:
measure: biliary complications resulting from omitted prophylactic cholecystectomy
timeFrame: 5 years
Secondary outcomes:
measure: safety of concurrent cholecystectomy
timeFrame: 30 days
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of surgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Martin Thurnheer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018966: Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
Official title: Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.


Eligibility criteria: Inclusion Criteria:

* 20 years or older
* Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors

Exclusion Criteria:

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2

Primary outcomes:
measure: To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT)
timeFrame: 3-week treatment cycles until unacceptable toxicity
Secondary outcomes:
measure: To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria
timeFrame: 3-week treatment cycles
measure: To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot
timeFrame: Cycle 1 (first 3 weeks of study therapy)
measure: To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 3-week treatment cycles until unacceptable toxicity
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01548066: The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Official title: The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Androgenetic Alopecia
Male Pattern Baldness
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Amorepacific Corporation
First posted: 2012-03-08
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at low level through regulation by GSK-3, multifunctional serine/threonin kinase. After phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore, inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been studied yet.


Eligibility criteria: Inclusion Criteria:

* age: 19 years \~ 45 years
* subjects with AGA (Hamilton\&Norwood grad III\~IV)
* subjects who are able to be followed for next 24 weeks.

Exclusion Criteria:

* subjects with severe medical problems including cardiovascular diseases, renal problems, and chronic metabolic disease
* subjects with AGA treated with surgical methods (hair TPL)
* subjects who has ever applied minoxidil in recent 3 months or has taken finasteride or dutasteride in recent 6 months.
* subjects who took medicine which can affect the hair growth
* subjects with alopecia other than AGA

Primary outcomes:
measure: linear hair growth rate
timeFrame: 24th week
Secondary outcomes:
measure: final hair density
timeFrame: 24th week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Seoul National University Hospital
Study officials:
affiliation: Seoul National Univeristy Hospital
name: Oh Sang Kwon, Prof.
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Seong Jin Jo, Fellow
role: STUDY_DIRECTOR
References:
Clinical trial NCT01754766: AGN-229666 for the Treatment of Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Japanese patients living in Japan with a history of allergic conjunctivitis
* Willing to discontinue wearing contact lenses during the study period

Exclusion Criteria:

* Use of nicotine products during the study period
* Presence of active eye infection (bacterial, viral, or fungal)
* History of an ocular herpetic infection
* Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months

Primary outcomes:
measure: Ocular Itching Score at Day 1
timeFrame: Day 1
Secondary outcomes:
measure: Ocular Itching Score at Day 15
timeFrame: Day 15
measure: Conjunctival Hyperemia Score
timeFrame: Day 1
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01313026: Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation
Official title: Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Cancer
Keywords: Percutaneous nerve evaluation
Transanal irrigation
Low anterior resection syndrome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-03-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomised trial testing the effect of percutaneous nerve evaluation and transanal irrigation on bowel function in patients after low anterior resection for rectal cancer.

Detailed description: Patients will undergo anal physiological assessment and will then be randomized to either treatment arm. The first 12 weeks they will be optimized in the conservative treatment of their bowel function before beginning active treatment with TAI or PNE. After 8 and 4 weeks respectively, the treatment will stop and they will have a period of 4 weeks back on optimized conservative treatment before beginning active treatment in the other active arm.

Detailed records of bowel, micturition and sexual function and QoL will be obtained at regular intervals during the entire trial fase.

Eligibility criteria: Inclusion Criteria:

* Low anterior resection for rectal cancer between May 2001 and May 2011

Exclusion Criteria:

* Non-radical resection
* metastatic disease
* Chemotherapy
* Radiotherapy
* Previously treated for another cancer
* Dementia or other mental retardation/severe mental disease
* Inability to read and understand the Danish language
* Recurrent disease

Primary outcomes:
measure: changes in LARS score
timeFrame: baseline, 12, 16, 20, 24 and 28 weeks
Secondary outcomes:
measure: Sexual function
timeFrame: baseline, 12, 16, 20, 24 and 28 weeks
measure: Bladder function
timeFrame: baseline, 12, 16, 20, 24 and 28 weeks
measure: Incontinence
timeFrame: baseline, 12, 16, 20, 24 and 28 weeks
measure: Patient Satisfaction
timeFrame: baseline, 12, 16, 20, 24 and 28 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Colorectal Surgical Department P, Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Katrine J. Emmertsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05170126: A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Official title: ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Ozanimod
Pregnancy
Outcomes
Obstetric
Infant
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 1182
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include pregnant women of any age who reside in the United States, Canada or Germany.

Brief summary: The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Multiple sclerosis (MS)
* Currently or recently pregnant
* Reside in the United States, Canada or Germany.

Exclusion Criteria:

• Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Major congenital malformations
timeFrame: Up to first year of life
Secondary outcomes:
measure: Minor congenital malformations
timeFrame: Up to first year of life
measure: Pre-eclampsia
timeFrame: Through pregnancy
measure: Eclampsia
timeFrame: Through pregnancy
measure: Spontaneous abortion
timeFrame: Through pregnancy
measure: Stillbirth
timeFrame: Through pregnancy
measure: Elective termination
timeFrame: Through pregnancy
measure: Preterm birth
timeFrame: Through pregnancy
measure: Small for gestational age
timeFrame: Up to first year of life
measure: Postnatal growth deficiency
timeFrame: Up to first year of life
measure: Infant developmental deficiency
timeFrame: Up to first year of life
measure: Perinatal death
timeFrame: Up to first year of life
measure: Neonatal death
timeFrame: Up to first year of life
measure: Infant death
timeFrame: Up to first year of life
measure: Serious or opportunistic infant infection (SOI)
timeFrame: Up to first year of life
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: ZEPOSIA MS Pregnancy Registry
state: North Carolina
city: Wilmington
country: United States
facility: ZEPOSIA MS Pregnancy Registry
state: North Carolina
city: Herne
country: Germany
facility: Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04508426: Single-dose AME Study With [14C]AR882 in Healthy Male Subjects
Official title: A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Arthrosi Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2020-08-11
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of \[14C\]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.


Eligibility criteria: Inclusion Criteria:

* Body weight no less than 50 kg and body mass index (BMI) within the range of ≥ 18 and ≤ 33 kg/m2
* Must have a minimum of 1 bowel movement every 2 days
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs

Exclusion Criteria:

* Inadequate venous access or unsuitable veins for repeated venipuncture
* Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies, and/or Hepatitis B

Primary outcomes:
measure: Total radioactivity (TRA) in urine
timeFrame: Days 1-14
measure: TRA in feces
timeFrame: Days 1-14
measure: TRA concentration equivalents in plasma
timeFrame: Days 1-14
measure: TRA concentration equivalents in whole blood
timeFrame: Days 1-14
measure: Area under the curve (AUC) for plasma [14C]-AR882
timeFrame: 7 Days
measure: Time to maximum plasma concentration (Tmax) for [14C]-AR882
timeFrame: 7 Days
measure: Maximum plasma concentration (Cmax) for [14C]-AR882
timeFrame: 7 Days
measure: Apparent terminal half-life (t1/2) for [14C]-AR882
timeFrame: 7 Days
Secondary outcomes:
measure: Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882
timeFrame: Days 1-14
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion, Inc.
state: Nebraska
Study officials:
References:
Clinical trial NCT05289726: Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105
Official title: Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hand and Foot Skin Reaction
Colorectal Cancer Stage IV
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities

Detailed description: this is an double blinded controlled preventive study to evaluate the preventive effect of this is an preventive traditional chinese medicine TDX105 plus Urea Ointment compared with placebo plus Urea Ointment on Regorafenib induced Dermatologic Toxicities

Eligibility criteria: Inclusion Criteria:

1. Clinically confirmed colorectal cancer patients;
2. It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;
3. Performance Status score ≤3;
4. Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms

6. Understand and agree to accept the treatment, and sign the informed consent.

Exclusion Criteria:

1. Patients with skin reactions affected by simultaneous use of other targeted drugs (sorafenib, sunitinib, fruquintinib, etc.), chemotherapy drugs (capecitabine, doxorubicin, etc.) or hand-foot radiotherapy;
2. Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;
3. Patients in the study who cannot cooperate with the continuation of this treatment;
4. Sudden changes in the patient's condition affected and interfered with the researcher

Primary outcomes:
measure: incidence of grade 3 hand-foot skin reaction
timeFrame: Once a week from the beginning to 2 months
Secondary outcomes:
measure: Grade 1-2 hand and foot skin reaction rate
timeFrame: Once a week from the beginning to 2 months
measure: Withdrawal rate of regorafenib within 2 cycles
timeFrame: Once a week from the beginning to 2 months
measure: progression-free survival
timeFrame: Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
measure: tumor control rate
timeFrame: Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer hospital Chinese academy of Medical sciences
state: Beijing
Study officials:
References:
Clinical trial NCT00132626: Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome
Official title: Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Parkinsonian Syndrome
Keywords: parkinson
diagnosis
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
Collaborators: name: Molecular NeuroImaging
name: National Institutes of Health (NIH)
First posted: 2005-08-22
Enrollment: 500
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, \[123I\]ß-CIT, in research participants with Parkinson's disease.

Detailed description: The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.

After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with \[123I\]ß CIT, an investigational radioactive material that localizes in the brain.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.

Eligibility criteria: Inclusion Criteria:

* At least 21 years of age
* Normal screening laboratory studies
* At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment

Exclusion Criteria:

* Pregnancy
* Significant medical disease including abnormalities found on screening

Primary outcomes:
measure: CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
Secondary outcomes:
measure: Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred
Other outcomes:
Locations:
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Kenneth Marek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06386926: Radial Shockwave Versus Ultrasound Phonophoresis
Official title: Radial Shockwave Versus Ultrasound Phonophoresis in Management of Chronic Supraspinatus Tendinitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Supraspinatus Tendinitis
Keywords: Shockwave , phonophoresis , supraspinatus tendinitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy)


Eligibility criteria: Inclusion Criteria:- BMI 18.5-24.9

* 18 years to 60
* with Unilateral Chronic Supraspinatus Tendinitis.
* Tenderness is found over the supraspinatus as it passes sub-acrominal and anterolateral.
* The patient reported with positive Jobe's test (empty can test)
* The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and overhead playing athletes).
* The patient reported pain with resisted isometric abduction

Exclusion Criteria:

* Case reports, treatments after surgery, did not meet our specified outcome parameters, traumatic incidents,
* Partial tears at surgery
* Massive retracted tears at surgery
* Frozen shoulder.
* Rotator cuff tear.
* Glenohumeral or acromioclavicular arthritis

Primary outcomes:
measure: change in the thickness of supraspinatus tendon
timeFrame: before start of treatment and 4 weeks following end of treatment
measure: change in pain intesity
timeFrame: before start of treatment and 4 weeks following end of treatment , score from 0-10 ,0=no pain , 10= unbearable pain
measure: Change in shoulder range of motion
timeFrame: before start of treatment and 4 weeks following end of treatment
Secondary outcomes:
measure: Function of the Upper Limb
timeFrame: before start of treatment and 4 weeks following end of treatment, it measure the disability/symptom section (11 items, scored 1-5)
measure: measure weight in kg and height in cm
timeFrame: before starting the assessment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
References: