louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01422915: Sorbent Therapy of the Cutaneous Porphyrias
Official title: Sorbent Therapy of the Cutaneous Porphyrias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Erythropoietic Protoporphyria
Keywords: Sorbent
Resin
EPP
Cutaneous porphyria
Adult
over age 21
without intercurrent illness
not pregnant
willing to participate
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-08-25
Enrollment: 4
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators demonstrated that cholestyramine is an effective binding agent in vitro for porphyrins. A few isolated case reports of treatment of individuals with a cutaneous porphyria suggest that cholestyramine and colestipol effectively remove porphyrins. Hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).

Detailed description: Four adults with proven EPP volunteered as subjects for this study. First period: Subjects received 1 gm colestipol twice daily for \~45 days, then 2 gm twice daily for \~45 days. Labs included CBC; liver chemistries including cholesterol; serum iron, TIBC and ferritin; erythrocyte and plasma protoporphyrin concentrations; and completion of sun exposure questionnaire focused on cutaneous manifestations every 2-4 weeks. Second period: Subjects received colestipol tablets, 2 grams twice daily, completing the sun exposure questionnaire and protoporphyrin determinations \~monthly for 5-6 months.

Eligibility criteria: Inclusion Criteria:

* Adult over age 21
* healthy

Exclusion Criteria:

* Intercurrent illness
* pregnancy

Primary outcomes:
measure: Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance
timeFrame: At 60 days of treatment
measure: Protoporphyrin Concentration in Blood
timeFrame: Samples collected while on treatment (range 93-208 treatment days)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05928715: Effect of Finger Feeding
Official title: Effect of Finger Feeding on Term Newborns: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Finger Feeding
Alternative Feeding Methods
Keywords: Finger Feeding
Lead sponsor: Amasya University
Sponsor class: OTHER
Collaborators: name: Mustela Foundation
First posted: 2023-07-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: With the planned study, it was aimed to determine the effect of finger feeding method on newborns in term babies.

Detailed description: It was planned as a randomized controlled experimental study design.

Full randomization will be performed and infants who meet the inclusion criteria will be assigned to groups by flipping a coin.

On the toss of a coin, if heads came up then subject was allocated to the control group. If tails came up, then subject was allocated to the intervention group. This procedure was repeated for each mother.

Within the scope of the study, "Informed consent" will be obtained from the parents for infants who need formula supplementation or for infants fed with expressed breast milk by the decision of the Physician in the experimental and control groups.

Babies in the control group will continue to receive routine care and no intervention will be made on their feeding style. The researcher will be informed verbally and practically about the finger feeding method and the application steps to the mothers of the babies in the experimental group and to the family members who will support their feeding in baby care. In this direction, it will be ensured that expressed breast milk or formula support is given by finger feeding method.

Eligibility criteria: Inclusion Criteria:

Mother is 18 years or older Newborns 38 weeks and older Newborns who do not have any postnatal health problems and are followed up with the mother Babies taking formula supplements Babies who have difficulty breastfeeding There is no obstacle to breastfeeding or breastfeeding

Exclusion Criteria:

Babies with sucking and swallowing dysfunction Babies with respiratory distress (respiratory rate over 60/min, babies with groaning, nasal wing breathing)

-

Primary outcomes:
measure: Breastfeeding
timeFrame: 15 days after the start of the intervention
measure: Expressed breast milk
timeFrame: 15 days after the start of the intervention
measure: Formula intake
timeFrame: 15 days after the start of the intervention
measure: finger feeding
timeFrame: 15 days after the start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT02903615: Optimising Health in Type 1 Diabetes
Official title: The Optimal Diet for Optimising Health in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: glucose
inflammation
Lead sponsor: Garvan Institute of Medical Research
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency, whereby blood glucose levels rise and diabetes develops. When there is severe insulin deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin replacement therapy; dietary intervention is a also cornerstone of glucose management.

The Optimise Diet is a multi-pronged diet based on "best health" principles: to minimise blood glucose rises after eating, reduce the immune cells involved in destruction of the insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In this study, its effects will be compared to the Standard Diabetes Diet that is currently recommended in Australia and internationally.

Detailed description: The rationale for this study is to determine whether a diet based on recent scientific advances in diet-induced inflammation, will improve diabetes care in people with type 1 diabetes.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.

Primary outcomes:
measure: Glucose control
timeFrame: 3 months
Secondary outcomes:
measure: Inflammation
timeFrame: 3 months
measure: Gut microbiome
timeFrame: 3 months
measure: C-peptide
timeFrame: 3 months
measure: postprandial glucose excursion
timeFrame: 3 months
measure: Follow-up of glycemic control and insulin secretion
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: professor Katherine Samaras
state: New South Wales
city: Sydney
country: Australia
facility: Garvan Institute to Medical Research
Study officials:
affiliation: Garvan Institute of Medical Research
name: Katherine Samaras, MD PhD FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01688115: Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase
Official title: Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Anxiety
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of a video shown using an iPad, compared to a standard treatment, to reduce preoperative anxiety in children who have to undergo to elective surgery procedure


Eligibility criteria: Inclusion Criteria:

* Age between 6 and 11
* No cerebral impairment or cognitive impairment
* Child and his/her family native speaker of Italian
* admission to the hospital at list one day before the sugery procedure
* presence of written consent of the parents to the study

Exclusion Criteria:

* age lower than 6 or upper than 11
* presence of cerebral impairment or cognitive impairment
* Child and his/her family are not native speaker of Italian
* absence of written consent of the parents to the study

Primary outcomes:
measure: Preoperative anxiety
timeFrame: perhaps 24 hours from child admission to surgery procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):e160533. doi: 10.1001/jamapediatrics.2016.0533. Epub 2016 Aug 1.
Clinical trial NCT02525315: Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenic Disorders
Keywords: Schizophrenia
auditory hallucinations
TMS
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating. Behavioral disorders associated with them can have serious social repercussions. However, in 25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective.

Fifteen subjects will be included after collection and signed their informed consent.

The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay below the risk of occurrence of seizures, the only serious side effects identified. Furthermore the rTMS treatment is almost painless: tension headaches are the main side effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The LEFT stimulation site will be established through a anatomofunctional imaging before treatment (between D-7 and D0).

Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the first 2 weeks of starting treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenic disorders aged from 18 to 60 years old
* Patients suffering from auditory hallucinations undergoing antipsychotic treatments
* Written signed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Counter-indication to MRI or to rTMS

Primary outcomes:
measure: HOFFMAN score
timeFrame: change between baseline and day 3 or day 12
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Sonia Dollfus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05853315: BCC Excision Revisited
Official title: Long-term Results After Surgical Basal Cell Carcinoma Excision in the Eyelid Region: Revisited
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Eye Diseases
Eye Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 451
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female patients with periocular basal cell carcinoma

Brief summary: To readdress basal cell carcinoma (BCC) in the periocular region to prove histologically controlled surgical treatment efficacy and to identify high-risk characteristics.


Eligibility criteria: Inclusion criteria:

* Patient records were reviewed for the presence of BCC and surgical excision with frozen sections control of the wound margins in the periocular region,
* conducted between 01.01.2009 and 31.12.2019.
* Periocular was defined as the area involving the medial and lateral canthus as well as the upper and lower eyelids.

Exclusion criteria:

* BCCs outside of this region were excluded from this analysis,
* as well as incomplete records.

Primary outcomes:
measure: BCC Recurrence
timeFrame: mean 3-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01487915: Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma
Official title: Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Urothelial Carcinoma
Keywords: Cisplatin-unfit condition
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 80
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: Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma.

But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice.

Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities.

But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens.

GemOx has been reported to be effective and have very favorable toxicity profiles.


Eligibility criteria: Inclusion Criteria:

* Cytologically of histologically confirmed urothelial carcinoma
* Locally advanced or metastatic disease
* Measurable disease according to RECIST v.1.1
* ECOG PS 0-2
* Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2)
* Adequate organ function
* Chemotherapy-naive

Exclusion Criteria:

* Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed
* CNS metastases
* Peripheral neuropathy grade 2 or worse
* Serious medical or surgical conditions

Primary outcomes:
measure: Response rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety
timeFrame: 12 months
measure: Progression-free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyeong University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
Study officials:
References:
citation: Park I, Kim BS, Lim HY, Kim HJ, Lee HJ, Choi YJ, Park KH, Lee KH, Yoon S, Hong B, Hong JH, Ahn H, Lee JL. Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16). Eur J Cancer. 2020 Mar;127:183-190. doi: 10.1016/j.ejca.2019.08.034. Epub 2019 Oct 24.
Clinical trial NCT00070915: Massage, Meditation, and Tai Chi for Chronic Lower Back Pain
Official title: Relaxation-Related CAM Therapies for Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2003-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This clinical trial is a preliminary study designed to prepare for a full-scale, randomized clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for chronic lower back pain in adults.

Detailed description: Despite the common use of complementary and alternative therapies for back pain, little is known about how such therapies compare with each other or with conventional medical therapies in terms of effectiveness and cost. This study will lay the groundwork for a full-scale trial that will evaluate the relative effectiveness and costs of three promising relaxation-related techniques (massage, tai chi, and meditation) that are appropriate for both younger and older adults with chronic lower back pain. The pilot study will identify and resolve unanticipated problems and estimate the sample sizes required for an adequately-powered, full-scale trial.

Participants with chronic lower back pain will be randomly assigned to one of the following groups: tai chi, massage, meditation, or continued usual care (control group). The participants assigned to each intervention will be divided equally between persons under and over age 65.

Eligibility criteria: Inclusion Criteria

* Chronic lower back pain

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Center for Health Studies
name: Daniel C. Cherkin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06442215: Selection of Surgical Technique in Rectal Cancer
Official title: Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Neoplasms
Keywords: Rectal cancer
Surgery
Minimal invasive surgery
Oncological outcomes
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 333
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: Patients diagnosed with rectal neoplasia undergoing elective surgery during a period of time from 2017 to 2021

Brief summary: Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.

Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.


Eligibility criteria: Inclusion Criteria:

* Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision.
* Age ≥ 18 years.
* Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy.
* Initial stage T1-T4a. Any N. Any M.
* Intention for R0 resection.

Exclusion Criteria:

* Colorectal tumor with histology different from adenocarcinoma.
* Synchronous colon tumor.
* Benign pathology or adenoma.
* Tis.
* T4b or oncological multivisceral resections.
* History of neoplastic colorectal surgery or local excision or TAMIS.
* Perforated or obstructive rectal neoplasm.

Primary outcomes:
measure: Suboptimal oncological outcomes
timeFrame: 15 postoperative days
Secondary outcomes:
measure: Surgical and Postoperative complications
timeFrame: 30 postoperative days
measure: Overall and disease free survival
timeFrame: 3-years surgery
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta de Girona
Study officials:
References:
Clinical trial NCT00540215: GLP-2 (Glucagonlike Peptide-2) and Blood Flow
Official title: The Role of GLP-2 in Univercal Changes in Blood Flow in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Blood Flow
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2007-10-05
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: It is the study aim to investigate the effect of glp-2 on blood flow in humans. we wish to study eventual changes in renal blood flow, carotic blood flow and cardiac out put.

GLP-2 will be administered subcutaneously, and the effect monitored by doppler ultra sound scannings and cotinuesly measuring of cardiac out put and blood pressure.

The study will include 15 healhty volunteers, 10 wil receive 450 nmol GLP-2 and 5 will receive 1 ml of isotonic saline (as baseline reference).

Detailed description: se the above

Eligibility criteria: Inclusion Criteria:

* Age 20-60
* Healthy
* No medication
* Not pregnant

Exclusion Criteria:

* All of the persons not meeting the abowe mentioned criteria

Primary outcomes:
measure: effect of glp-2
timeFrame: during study
Secondary outcomes:
measure: potential new ideas for further studies
timeFrame: months to years
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
state: Region Hovedstaden
Study officials:
affiliation: Glostrup university hospital
name: lasse bremholm, MD
role: PRINCIPAL_INVESTIGATOR
References: