linjc16/ctgov huggingface dataset:
Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: MOA-728
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer. Taking oral, transdermal, intravenous, or subcutaneous opioids. Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives. Exclusion Criteria: History of chronic constipation before the initiation of opioid therapy. Other GI disorders known to affect bowel transit. Women who are pregnant, breast feeding, or plan to become pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: 150 mg<br>MOA-728 | Drug: MOA-728<br>* Oral Capsules<br>|
| Experimental: 300 mg<br>MOA-728 | Drug: MOA-728<br>* Oral Capsules<br>|
| Experimental: 450 mg<br>MOA-728 | Drug: MOA-728<br>* Oral Capsules<br>|
| Experimental: 600 mg<br>MOA-728 | Drug: MOA-728<br>* Oral Capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment |  | 3 hours |
Inflammatory Response in Laparoscopic and Open Colectomy

Study Overview
=================
Brief Summary
-----------------
This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery

Official Title
-----------------
Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: Laparoscopic colectomy
* Procedure: Open colectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colorectal cancer Exclusion Criteria: metastases stage 4 colorectal cancer recurrent disease chronic diseases obvious inflammatory condition
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Surgery group<br>Group of patients that are operated with laparoscopic approach | Procedure: Laparoscopic colectomy<br>* Laparoscopic colectomy. Epidural anaesthesia used<br>|
| Active Comparator: Open surgery Group<br>Group of patients operated with open approach | Procedure: Open colectomy<br>* Open colectomy. Epidural anaesthesia used<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer |  | preoperative, intraoperative, 6h postop, 24h postop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
a-defensins, TLRs, Inflammatory Cytokines, CRP, No metastases, No other obvious inflammation, No chronic diseases
Estrogen Alternatives Study

Study Overview
=================
Brief Summary
-----------------
Healthy postmenopausal women not currently taking hormone replacement or hormone modulating therapy take a 3-month course of estradiol/raloxifene/placebo to evaluate the effects of each on vascular function, as indicated by PET coronary flow reserve studies and brachial artery ultrasound, before and after use of the therapies. This is a randomized, placebo-controlled, blinded study.

Official Title
-----------------
Estrogen Alternatives and Vascular Function in Post-Menopausal Women

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Estradiol followed by progesterone
* Drug: Raloxifene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women (no menses for greater than or equal to 12 months, or s/p [status post] hysterectomy with bilateral ovariectomy) not currently taking hormone replacement therapy (within previous 3 months) Normal mammogram within previous 12 months Exclusion Criteria: Current or recent (within previous 3 months) hormone replacement therapy Current or recent (within previous 3 months) use of hormone alternatives such as raloxifene, tamoxifen, or soy estrogen preparations. LDL Cholesterol > 160 mg/dl. History of hypertension, diabetes mellitus, peripheral vascular disease, cerebrovascular disease, current smoking, history of DVT (deep vein thrombosis) or PE (pulmonary embolism), active gallbladder disease, family history of premature (men under 55 yrs, women under 65 yrs) coronary artery disease History of breast, uterine, or ovarian cancer Contraindication to adenosine administration (i.e., significant bronchospastic pulmonary disease, higher degree heart block) Inability to give informed consent Inability to temporarily (for 24 hours) discontinue potential vasoactive drugs, such as anti-inflammatory agents and aspirin, at least 24 hours prior to the examinations. History of coronary heart disease
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Estradiol followed by progesterone|nan|
|Drug: Raloxifene|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial function, hormone replacement therapy, coronary flow reserve, posmenopausal women, women's cardiovascular heatlh
Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare and determine the the efficacy of minimal stimulation and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic Ovary Syndrome(PCOS).

Detailed Description
-----------------
All patients received 100 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. In group A (minimal stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland, 75 IU/vial) were given IM on cycle day 9. A total of 3 cycles was offered to each group.

Official Title
-----------------
Minimal Stimulation or Clomiphene Citrate as First Line Therapy in Women With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: clomiphene citrate +highly purified uFSH
* Drug: clomiphene citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS No other infertility factors No previous use of ovarian stimulation drugs Exclusion Criteria: Congenital adrenal hyperplasia Cushing syndrome Androgen secreting tumors

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minimal stimulation protocol<br>5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles | Drug: clomiphene citrate +highly purified uFSH<br> <br> |
| Active Comparator: clomiphene citrate(CC)<br>5 days of CC (100mg/day) from cycle day 3 for three treatment cycles. | Drug: clomiphene citrate<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate per cycle |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness at the time of hCG administration |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic ovary syndrome, clomiphene citrate, minimal stimulation, infertility treatment
The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP)

Study Overview
=================
Brief Summary
-----------------
Chronic nonspecific neck pain (CNNP) is a public health issues with a 50% life prevalence. CNNP is a leading cause of disability which contributes to higher costs due to loss of productivity, disability, and increased absenteeism from work. Yoga has been found effective managing neck pain but there has been no study at work setting for chronic non-specific neck pain. To determine the effectiveness of Yoga@work program for chronic non specific neck pain among office workers, present randomised controlled trial was undertaken.

Official Title
-----------------
The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP): A Randomised Controlled Trial.

Conditions
-----------------
Chronic Non-Specific Neck Pain

Intervention / Treatment
-----------------
* Other: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who gave written informed consent Having neck pain for more than 3 month Exclusion Criteria: Systematic disorder Neck or spine injuries Recent surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Group<br>The yoga group received the 8-week yoga sessions at work setting once a week by trained teacher followed by self practices. | Other: Yoga<br>* Yoga@work program included physical movements, yoga posture, breathing exercise, pranayama and yoga chants. Session with trainer was conducted on worksite once a week for an hour.<br>|
| No Intervention: Control Group<br>Participants had one introductory session on proper physical position and stretching exercises to be practiced daily during work. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Pain | Pain was measured using Visual Analogue Scale | Change from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | HRQoL was measured with the Short Form 36 | Change from baseline to 8 weeks | 
| Neck function | Neck functions with Northwick Park Neck Pain Questionnaire | change from baseline to 8 weeks |
Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury

Study Overview
=================
Brief Summary
-----------------
this study designed to examine the effect of Acu-TENS applied bilaterally on Ding Chuan acupoint to boost pulmonary functions, improve diaphragmatic excursion and decrease dyspnea in patients with inhalation injuries.

Official Title
-----------------
Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury

Conditions
-----------------
Inhalation Injury

Intervention / Treatment
-----------------
* Device: acupoint TENS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partial or full-thickness major burns Diagnosis of smoke inhalation based on the history of smoke exposure and chest computed tomography (CT) Have no systemic disease Body mass index less than 30. Exclusion Criteria: Patients with any other pulmonary condition Cardiac condition Rib fracture Systemic disease Local infection and cigarette or tobacco use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS Therapy Group<br>patients received acupoint TENS | Device: acupoint TENS<br>* TENS was applied bilaterally on acupoint Ex-B1, 4Hz frequency, and 200 μs pulse width and intensity was set at the best highest tolerable intensity by the patient sensitivity without a sensation of discomfort for 45 minutes, three times/week for four weeks<br>|
| Sham Comparator: Control group<br>patients received shame acupoint TENS | Device: acupoint TENS<br>* TENS was applied bilaterally on acupoint Ex-B1, 4Hz frequency, and 200 μs pulse width and intensity was set at the best highest tolerable intensity by the patient sensitivity without a sensation of discomfort for 45 minutes, three times/week for four weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometer | • Portable spirometer to measure forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) from setting position. | 4 weeks |
Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
PTSD is a common consequence of war, for soldiers and civilians. PTSD results in hyperarousal, avoidance, numbing, and re-experiencing, causing persistent decreased quality of life. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health. Within health care, mindfulness is taught as an 8-week course called Mindfulness-Based Stress Reduction (MBSR). MBSR is unstudied for PTSD. We propose to assess the feasibility of MBSR as an intervention for PTSD, since it may affect hypervigilance, avoidance, and reactivity associated with this disorder. Specific Aims: Aim 1: Assess the feasibility of recruiting and retaining a sample of veterans with PTSD to complete a study protocol that involves randomization to usual care or usual care plus MBSR. Aim 2: Apply measures of PTSD symptom severity, depression and quality of life before and after randomization, to assess whether there is evidence of benefit and whether MBSR warrants further study for PTSD, and allow calculation of standardized effect sizes. Aim 3: Apply a validated measure of mindfulness before and after treatment. Aim 4: Explore the relationship between PTSD symptoms, mindfulness score, and frequency of meditation practice.

Official Title
-----------------
Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study

Conditions
-----------------
Stress Disorders, Post-Traumatic, Depression

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based stress reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have PTSD Exclusion Criteria: Active substance use Active suicidal ideations Borderline or antisocial personality disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR<br>An 8-week course in mindfulness-based stress reduction (MBSR) | Behavioral: Mindfulness-based stress reduction<br>* An 8-week course in mindfulness training<br>|
| No Intervention: 2<br>Treatment as usual | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptom score |  | baseline, after MBSR and 4 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression (PHQ9) |  | baseline, after MBSR and 4 months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, mindfulness, trauma
Narrowband UVB Light Therapy to Patients With Dark Skin Types Who Have 10% of Their Body Involved With Psoriasis Vulgaris.

Study Overview
=================
Brief Summary
-----------------
This study offers narrowband UVB light therapy to patients with both light and dark skin types who have 10% of their body involved with psoriasis vulgaris.

Detailed Description
-----------------
Two groups of patients, having 10% of their body surface area involved with psoriasis vulgaris, will receive narrowband phototherapy. One group will have skin type I-IV, or light skin and the second group will have dark skin, or type V-VI. All patients will receive phototherapy, with narrowband UVB, three times a week for six weeks, or a total of 18 treatments. 6mm punch skin biopsies will be done prior to starting therapy and at the completion of the study. Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) of both groups will be compared.

Official Title
-----------------
A Study To Determine the Efficacy of Whole Body Narrowband UVB Phototherapy in People With Darker Skin Types

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Device: Phototherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have stable psoriasis vulgaris, which covers at least 10% of their bodies, for at least six months. Patients can not have not been treated with narrowband UVB in the past, although other light therapies are acceptable (i.e. broadband UVB and PUVA). Patients are not allowed to receive other therapies for their psoriasis, internal and topical, while they are participating in the study. Patients may continue using non-medicated moisturizer. - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBUVB<br> | Device: Phototherapy<br>* The patient begins total body NBUVB that day at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until clearance of disease or maximum efficacy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and histological improvement of psoriasis |  | beginning and end of treatment |
Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques

Study Overview
=================
Brief Summary
-----------------
In this study the researchers want to retrospectively compare non-refluxing ureteroneocystostomy (UNC techniques to reflux UNC techniques in paediatric kidney recipients with regard to urinary tract infections and uteral obstruction.

Detailed Description
-----------------
Multi-center retrospective study and survey on clinical practice among different urologists. The researchers will retrospectively study data on patients that received their kidney graft between 1994-2018 in either Radboudumc or UW Health University Hospital in Winsconsin. Additionally, all urologist currently employed at those hospitals will be asked to fill in a survey on preferences in UNC techniques and suture material.

Official Title
-----------------
The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation

Conditions
-----------------
Kidney Transplant; Complications, Kidney Transplant Infection, Kidney Transplant Failure and Rejection

Intervention / Treatment
-----------------
* Procedure: UNC technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: received kidney graft in the participating centres at an age <19 received kidney graft between 1994-2018 follow-up data of at least 1 year Exclusion Criteria: - Loss of follow up < 1 year

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radboudumc recipients<br>NTX performed with a refluxing technique | Procedure: UNC technique<br>* In general, UNC techniques can be divided in being either intravesical or extravesical and refluxing or non-refluxing<br>|
| Winsconsin recipients<br>NTX performed with a non-refluxing technique | Procedure: UNC technique<br>* In general, UNC techniques can be divided in being either intravesical or extravesical and refluxing or non-refluxing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infections | Number of urinary tract infections (with fever) | 25 year | 
| Ureteral obstruction | Number of ureteral obstruction needing intervention | 25 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival | Percentage of patients with a functioning graft | 25 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplantation, Pediatrics