linjc16/ctgov huggingface dataset:
Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
A UK prospective, single-centre feasibility study investigating the effects of exercise therapy on functional capacity in patients on the waiting list for liver transplantation. Patients will receive a 12-week home prehabilitation program (daily step program; functional resistance exercise sessions; telephone health call or virtual clinic). The following will be assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety, patients perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS questionnaire) and quality of life (EQ-5D)

Detailed Description
-----------------
as above

Official Title
-----------------
Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation

Conditions
-----------------
Liver Cirrhosis, Liver Dysfunction

Intervention / Treatment
-----------------
* Behavioral: Home prehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the United Kingdom Liver Transplant criteria for listing Accepted on the liver transplant waiting list for a primary transplant Adults ≥18years who have an indication for a liver transplant Diagnosed with sarcopenia at liver transplant assessment Exclusion Criteria: Significant cardiovascular instability including a recent Myocardial infarction, recent Cerebrovascular accident and/or a recent unstable arrhythmia Unstable encephalopathy - open to interpretation by the chief investigator Patient or next of kin non-English speaking Inpatients Refusal or lacks capacity to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Intervention arm<br>12-week home prehabilitation program | Behavioral: Home prehabilitation program<br>* 12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with intervention-related adverse events as assessed by CTCAE v4.0 | As this is a feasibility/Pilot study the investigators need to assess if any participants have any adverse events related to the home prehabilitation programme and if so, determine the severity and frequency | 12-week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prehabilitation, liver transplant, functional capacity, exercise
Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to examine the effects of combined pharmacotherapy (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy patients.

Detailed Description
-----------------
This is a one-arm, open label pilot study of MMT patients to determine whether bupropion, nicotine replacement therapy, and behavioral counseling is a feasible and potentially effective intervention for smoking cessation. The smoking behaviors of participants will be be followed for 6 months post quit-date to determine effect-size estimates for a future, large scale trial.

Official Title
-----------------
Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Other: Combined intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in long-term methadone maintenance treatment Patient smokes at least 10 cigarettes per day, are stable on their use of methadone (phase 2 or higher treatment), smoked for at least 1 year, be willing to participate for 6 months, and not have used bupropion or nicotine replacement therapy for 6 months Exclusion Criteria: Patients who use prescription drug regimens that might affect methadone or bupropion metabolism Patients with cardiovascular disease, asthma, COPD Patients who are pregnant or breastfeeding Patients with regular use of alcohol, other illicit drugs, or other types of tobacco (chewing or pipe for example)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Combined Pharmacotherapy and Counseling<br>300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing | Other: Combined intervention<br>* 300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cigarettes smoked per day |  | six months |
Tourniquet Complications in Orthopaedic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to establish the number and nature of complications that we, the researchers, have with the use of a tourniquet in orthopaedic surgery in Norway.

Detailed Description
-----------------
This is a multicenter, prospective study where contact persons in 10 different hospitals throughout Norway monitor problems and complications that occur in relation with tourniquet use in orthopaedic surgery. If a complication occurs, it is documented in detail by the contact person.

Official Title
-----------------
A Prospective, Epidemiological Study of the Incidence and Nature of Tourniquet Complications in Norway

Conditions
-----------------
Tourniquet Complications, Paresis, Palsy, Nerve Compression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in 10 orthopaedic hospitals in Norway undergoing surgery which requires a tourniquet, from 1 january to 31 of december 2005
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Tourniquet, paresis
Social Adaptation in Long Term Survivors of Blood and Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
To explore specific aspects of social adaptation such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT). To investigate how social adaptation varies with time lapsed since BMT and with the life stage as determined by patient?s age. Understanding both the positive and negative aspects of cancer and cancer therapy leads to opportunities to promote adaptive strategies.

Official Title
-----------------
Social Adaptation in Long Term Survivors of Blood and Marrow Transplantation

Conditions
-----------------
Social Adaptation

Intervention / Treatment
-----------------
* Procedure: Semi structured personal interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lymphoma patients treated with blood and marrow transplantation at Stanford University Medical Center Age > 18 years at the time of transplant English speaking Willingness to sign a written informed consent document

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| autologous BMT recipients<br>Lymphoma patients who received an autologous BMT as adults | Procedure: Semi structured personal interview<br>* A trained research assistant will conduct in-person, in-depth semi-structured interviews at a location of the participants choosing. Participants will be asked to discuss their experiences with cancer, focusing especially on how their cancer affected their (1) work/education (2) relationships with their family (spouse, children, parents, siblings and other relatives) (3) their other social relationships<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific aspects of social adaptation, such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT) |  | 1 year | 
| Social adaptation variation with time lapsed since BMT and with the life stage as determined by patient's age |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood and Marrow Transplant (BMT)
Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia. This one time visit will collect zonulin levels, antibodies to gliadin (tissue transglutaminase and antigliadin antibodies) and other information that may relate to increased intracellular tight junction permeability as it related to the immune and stress system and the immune association with kynurenic acid pathway 50. Data will be collected for use in future grant applications and published reports.

Official Title
-----------------
Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin

Conditions
-----------------
Schizophrenia, Celiac Disease

Intervention / Treatment
-----------------
* Procedure: Blood Draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV Diagnosis of Schizophrenia or Schizoaffective Disorder Male or females between ages of 18 to 75 years Exclusion Criteria: Score below 10/12 on the Evaluation to Sign Consent (ESC)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Schizophrenia<br> | Procedure: Blood Draw<br>* One time blood draw<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zonulin concentration in serum (ng/mg) | Participants will undergo a one-time blood draw in order to test for zonulin concentration in serum (ng/mg) and these results will be compared to normative data to screen for elevations. The sample size for this pilot study was estimated based on the known prevalence of Celiac disease in schizophrenia, a disease known to have elevated zonulin levels. | 1 day |
The Effect of Acupressure and Reiki on Pain and Fatigue Levels

Study Overview
=================
Brief Summary
-----------------
This research was conducted with the aim of determining the effect of levels of pain and fatigue of acupressure and Reiki application on cancer patients receiving palliative care. The research was a single-blind, repeated measures, randomized controlled study. Research data were collected between February and July 2022. The research sample consisted of acupressure and Reiki application groups and a control group with 52 patients in each group, a total of 156 patients. Data was collected by means of a Patient Description Form, an Analgesic Follow-up Form, the Eastern Cooperative Oncology Group Performance Status Scale, the Numeric Pain Rating Scale, and the Brief Fatigue Inventory.

Official Title
-----------------
The Effect of Acupressure and Reiki on Pain and Fatigue Levels in Cancer Patients Receiving Palliative Care

Conditions
-----------------
Acupressure, Cancer Pain, Fatigue

Intervention / Treatment
-----------------
* Procedure: Acupressure intervention
* Procedure: Reiki intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having a diagnosis of third or fourth-stage cancer, being aged 18 years or older, having had pain for at least one month in connection with cancer treatment or the symptoms of the disease, using NSAII or non-opioid analgesics, having a status of 3 or more on the Numeric Pain Rating Scale (NPRS), having a score of 0-3 on the ECOG-PS scale Exclusion Criteria: having a diagnosis of first or second-stage cancer, being aged less than 18 years, having bone or brain metastasis, using opioid analgesics, having a status of less than 3 on the NPRS, having a status of between 4 and 5 on the ECOG-PS scale

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressure<br>Acupressure intervention | Procedure: Acupressure intervention<br>* Acupressure<br>|
| Experimental: Reiki<br>Reiki intervention | Procedure: Reiki intervention<br>* Reiki<br>|
| No Intervention: Control<br>No intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | A score of 0 indicates no pain, 1-3 slight pain, 4-6 moderate pain, and 7-10 severe pain . | on the second day of the starting week | 
| Brief Fatigue Inventory | It is scored between 0 and 10. | on the second day of the starting week |
Protocol for a Multicentre Survey of Patients With Treatment Resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
Project aims to determine the number of individuals with treatment resistant hypertension and to define the characteristics of these patients and estimate disease frequency. The study will be a retrospective review of medical record data based upon de-identified information and will require no patient contact.

Official Title
-----------------
Protocol for a Multicentre Survey of Patients With Treatment Resistant Hypertension

Conditions
-----------------
Treatment Resistant Hypertension

Intervention / Treatment
-----------------
* Other: N/A, observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > = 18 years of age No known secondary cause of hypertension History of uncontrolled hypertension while using 3 or more anti-hypertensive agents Controlled blood pressure using 4 or more different anti-hypertensive agents Exclusion Criteria: N/A

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


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: N/A, observational study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adult subjects with treatment resistant hypertension |  | one year |
Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

Study Overview
=================
Brief Summary
-----------------
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.

Official Title
-----------------
A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Azathioprine OR Mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years old Clinical remission at inclusion time (CDAI<150) Having ileocolonic or colon resection 21 days before inclusion Resection > 50cm or subtotal colectomy with ileorectal anastomosis Exclusion Criteria: Intolerance to one of both study treatment Liver failure (TP<60%) Renal Failure (Creatinine < Lab results)

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 |
| --- | --- |
| Active Comparator: 1<br>Azathioprine : 2mg/kg/day | Drug: Azathioprine OR Mesalazine<br>* Azathioprine : 2mg/kg/day Mesalazine : 4g/day<br>|
| Active Comparator: 2<br>Mesalazine : 4g/day | Drug: Azathioprine OR Mesalazine<br>* Azathioprine : 2mg/kg/day Mesalazine : 4g/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically and endoscopically recurrence at 12 and 24 months |  | 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, Ileocolic resection, Endoscopic recurrence, Ileocolic or colon resection (>50cm)
Neonatal Spinal Muscular Atrophy (SMA) Screening

Study Overview
=================
Brief Summary
-----------------
Parents or legal guardian of neonates who signed agreement will receive SMA screening test if their neonates are affected with SMA. The dried blood spots of routine newborn screening samples will be used to test if neonates have lost 2 copies of SMN1 gene. If neonates have positive SMA screening test, further confirmation with multiplex ligation-dependent probe amplification (MLPA) test and prospective motor function monitoring including physical and neurological examinations will be proved to make SMA confirmation. For any confirmed SMA patient, genetic counseling and standard of care will be proved.

Official Title
-----------------
Study on the Neonatal Screening of Spinal Muscular Atrophy

Conditions
-----------------
Spinal Muscular Atrophy

Intervention / Treatment
-----------------
* Other: SMA Newborn Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates born in Taiwan who receive regular newborn screening suggested by Ministry of Heath and Welfare. Parents or legal guardian agree to perform SMA newborn screening. Exclusion Criteria: Parents or legal guardian do not agree to perform SMA newborn screening.

Ages Eligible for Study
-----------------
Maximum Age: 2 Weeks

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: SMA Newborn Screening|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates with confirmed the deletion of 2 copies of SMN1 gene | Neonates with positive SMA newborn screening will be confirmed by multiplex ligation-dependent probe amplification (MLPA) test | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates with confirmed SMA | Neonates with confirmed the deletion of 2 copies of SMN1 gene by MLPA test will be followed till SMA symptoms appear. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Muscular Atrophy, Newborn Screening